Medical Device made Easy Podcast

Medboard Europe TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update -  New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system   EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf   UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report   Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?:  https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf   Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware. In this article, based on the podcast episode, we cover: How PMS differs for software, cloud, and AI-based devices Usage monitoring & anomaly detection through dashboards and KPIs Revalidation of updates and retrained AI algorithms Regulatory frameworks: EU MDR/IVDR, FDA’s PCCP, IMDRF guidelines Supplier and infrastructure considerations A step-by-step PMS workflow for QA/RA teams Real-world case study on AI performance drift 👉 We conclude with a practical checklist to help QA/RA teams ensure compliance while keeping patients safe. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical Innovation The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension of his life’s mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery. In this exclusive episode of the Medical Device Made Easy Podcast, host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a deep commitment to education. A Career Built on Medical Breakthroughs Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide. Why a Surgeon Became a CEO Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice. As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career. Patient Education as a Driving Force Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most. By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership. Building a Global Legacy Through Training Prof. Possover’s passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach. This dedication reflects a philosophy that medicine’s greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations. Lessons for Medical Professionals and Entrepreneurs This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business. Clinical expertise can fuel entrepreneurship when paired with strategic thinking. Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand. Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers. Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover’s journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership. In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage. Links INSP Link: https://isnp.possover.com/index neurogyn: https://neurogyn.com/ Possover: https://www.possover.com/en/ Youtube: https://www.youtube.com/results?search_query=marc+possover Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice  

bersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence. In this article (based on the podcast episode), we explore: How to prepare cybersecurity documentation for audits and inspections Building post-market processes for vulnerability handling and reporting Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…) Managing supplier and open-source component risks Implementing and maintaining an SBOM Key trends like the NIS2 Directive and the EU AI Act 👉 We finish with a practical checklist for QA/RA teams to assess their readiness today. Cybersecurity isn’t about perfection—it’s about showing regulators you are in control. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Medboard   EUROPE Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf Updated - Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf There's a significant backlog: far more applications submitted than certificates issued, especially for IVDs. Time for certification: between 13 to 18 months on average Delay due to application missing critical information and refusal due to submission outside NB scope No transparency on capacity Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770If device emit radiation and need clinical investigation in germany: Include a radiation risk assessment in your clinical investigation dossier Coordinate with Radiation protection authorities Update investigator brochure and patient information Stricter Monitoring & Reporting Impact on Timelines So stricter documentation, more authorities involved and longer approval times   UK MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout  -  https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device   Switzerland New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html 1 july-2026   Magazine Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1   Podcast: Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/   REST OF THE WORLD SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it:  USA: PCCP - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139 TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/ Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf  

Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does this mean for compliance professionals? Is AI a powerful tool to accelerate regulatory processes, or a risky shortcut that could jeopardize compliance? In this new episode of the Medical Device Made Easy Podcast, Monir El Azzouzi sits down with RJ Kedziora (Estenda) to explore the opportunities and risks of using AI in regulatory compliance. Together, they discuss: Why more QA/RA teams are experimenting with AI tools like ChatGPT, Gemini, Claude, and Grok How to integrate AI into different product design and regulatory phases The role of Prompt Engineering and why it matters in compliance Practical tips for creating effective AI prompts The warnings and risks you should keep in mind when relying on AI How agencies like the FDA are beginning to explore AI for dossier reviews 👉 If you want to stay ahead in the world of medical device compliance, this conversation is a must-li

Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304. In this episode of our podcast, we dive into the critical aspects of software update management for medical devices: Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of semantic versioning in regulated environments. Documentation & traceability – Why proper version control and documentation are essential for audits and compliance. Communication with stakeholders – Best practices for release notes, change logs, and informing users, regulators, and internal teams. Common pitfalls – Mistakes that lead to compliance risks and how to avoid them. Pro tips & resources – Actionable recommendations to strengthen your update and versioning strategy. Whether you are a software engineer, QA/RA professional, or regulatory affairs manager, this episode will give you practical tools and insights to build a robust, compliant, and audit-ready update process. 👉 Listen now and discover how to master the balance between innovation, safety, and compliance in medical device software.

From Zero to One: Mastering Client Collaboration in Consulting Starting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical Device Made Easy podcast, I share my personal path: from my early days in engineering to creating Simply Medica, and the lessons learned along the way. We discuss how to: Build credibility before calling yourself a consultant Turn your first project into a stream of referrals Use networking (both in-person and online) to grow Balance expertise with passion to create real impact For anyone starting out—or looking to strengthen client relationships—this is your roadmap from zero to one.

Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world. Adam’s journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising. What you’ll discover in this episode: 📈 How Adam transitioned into RAQA with no previous background ✅ The real day-to-day life of an ISO 13485 auditor — separating myths from reality ⚠️ Common mistakes consultants and auditors should avoid 🤝 What clients truly value when hiring a consultant 🚀 How to grow your consulting business organically 🤖 Adam’s next big step: creating an AI-powered audit tool to transform compliance work Whether you’re just starting your career in medical devices or thinking about launching your own consultancy, this episode offers honest, practical insights you won’t find in any textbook. 🎧 Listen now and gain a realistic perspective on what it takes to succeed in the highly regulated MedTech industry.

In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you're a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice. What you’ll learn: Why Mitch chose to specialize in QA/RA The tension between client expectations and candidate realities How recruiters make their revenue (yes, we ask the money question!) Whether promoting open positions is still a challenge in 2025 Mitch’s personal journey—education, family, and the struggles of building a business from scratch What he would do differently if he had to start again Whether you're considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go "from zero to one." 👉 Listen now and subscribe to our podcast to never miss a new episode! Linkedin: https://www.linkedin.com/in/mitchrobbins/ Website: https://theanthonymichaelgroup.com/

Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices, including those covered by transitional provisions and even non-medical products listed under Annex XVI. This shift marks a turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU. 🔎 What the regulation says: Manufacturers are allowed to provide eIFUs for professional-use devices, as long as the device is not likely to be used by laypersons. For any device that might be used at home or by a non-professional, a paper IFU is still mandatory. All versions of an eIFU—current and obsolete—must be hosted securely and remain accessible to authorities on request. The URL of the eIFU must be registered in EUDAMED's UDI database once that requirement becomes mandatory. 📌 Top 5 reasons why switching to eIFU makes sense: Broader regulatory permission This update grants manufacturers the freedom to digitize IFUs across their entire product line, simplifying regulatory planning and execution. Significant cost savings and faster updates With eIFUs, there’s no need for printing, translation management across packaging batches, or physical distribution—everything can be updated instantly online, cutting costs and time-to-market. Improved traceability and audit readiness Digitally managing eIFUs ensures version control, easy access for auditors, and a clean digital trail that supports internal QA systems. Better experience for healthcare professionals Healthcare professionals prefer electronic formats for their speed, searchability, and multilingual options—making your devices more user-friendly. Alignment with the EU’s digital vision By linking eIFUs directly with EUDAMED and UDI databases, you align your business with the evolving regulatory ecosystem and future-proof your documentation process. 🛑 But eIFU is not a one-size-fits-all solution. You still need paper IFUs in key scenarios: If your device could be used by laypersons, you must provide a paper version. In low-connectivity settings, such as field hospitals or rural clinics, physical IFUs may be more reliable. Adopting eIFU requires full platform readiness, including hosting, backups, multilingual versions, and internal QA validation. Regulatory responsibility is now entirely on the manufacturer—including website uptime, version archives, and EUDAMED linkage. Some stakeholders—including auditors and hospitals—still prefer traditional paper documentation, which could delay full adoption. 📽️ Watch our video to get a complete overview of the regulation and see how EasyIFU helps you implement a compliant, secure, and future-ready eIFU process. This is essential for RA/QA teams, product managers, and any manufacturer operating under MDR.

  Background: From IT in India to MedTech in Norway  You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)  What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?  And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)  Day-to-Day as a QARA Manager   Let’s talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)  It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?  We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?  On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?  (For example, is it challenging that the scope is so broad – one moment you’re deep in engineering specs, next moment you’re updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)  First MedTech Role at Hy5Pro AS  Let’s dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?  (Feel free to explain what Hy5Pro’s product was and your role there, e.g. implementing the quality system, getting certifications, etc.)  Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?  (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)  Leading QARA at RemovAid AS   After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?  RemovAid’s product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.  (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)  On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?  RemovAid is in women’s health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it’s about making contraceptive care easier – that’s quite impactful.)  Consulting Experience at LINK Medical   Now, currently you’re working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?  I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company’s project mid-stream.  Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you’ve learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*  Diversity and International Career Insights   I’d like to touch on diversity and your international experience. You’re a woman in the medtech industry and you’ve built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you’ve noticed working in Norway compared to India?  The medtech industry, especially in leadership, still isn’t very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?  What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)  Rapid-Fire Round   Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I’ll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!  Question 1: What’s one thing about your job that most people would be surprised to learn?  Question 2: What’s the coolest medical device or gadget you’ve worked on or seen so far?  Question 3: Are you team coffee or tea? (What fuels your workdays?)  Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?  Question 5: If you weren’t in QARA, what alternate career could you see yourself in?  Question 6: What’s one Norwegian word or phrase you’ve picked up that you love to use? (Bonus: translate it for us!)*  Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)  (Guest gives rapid-fire answers with laughter and brief commentary.)  Advice and Closing   Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?  (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)  And maybe equally important, what should they not be scared of? People might think “Oh, I’m not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?      Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)  Welcome & Setup  Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?  Career Journey  How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?  What motivated you to switch into medical device regulations, and what were the biggest initial challenges?  In what ways has your IT background helped you excel in QARA?  Day-to-Day Responsibilities  What does a typical day or week look like for you as a QARA Manager?  Which tools or software (QMS systems, document controls, etc.) do you rely on most?  Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it’s all paperwork?  Which aspects of QARA do you find most challenging, and which are the most rewarding?  Hy5Pro AS Experience  What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?  Can you share a memorable “learning moment” or funny anecdote from your time there?  RemovAid AS Experience  At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?  Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.  Any unexpected or humorous challenges you overcame in that role?  How did working on a women’s health product impact you personally?  LINK Medical Consulting  How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?  What’s a standout project or recurring compliance issue you help clients solve?  How do you stay organized when juggling multiple clients and deadlines?  Diversity & Interna

Guest: Stefan Bolleininger  Title: From Zero to One: Creating your Consulting Firm  Logo: Be on Quality   Telling the story behind Be on Quality,   the challenges for you,   the way you did grow the business,   the things you would do differently   cost  Sharing also the life of a CEO that did start this project.   How many hours are you working,   is it easy to disconnect,   what are your fears....   AI  What’s next for Be on Quality    Link:  Be on Quality:  https://www.be-on-quality.com/ Stefan Bolleininger Linkedin:  https://www.linkedin.com/in/stefan-bolleininger-3a717028/ Quick recap  Stefan shared his entrepreneurial journey from working in automotive quality management to founding and growing his medical device consulting company, which was later acquired by a French engineering firm and merged with his sister company in Switzerland. Through discussions with Monir about his business experiences, they explored topics including customer relationships, pricing strategies, and the challenges of managing company growth while maintaining quality and communication. Stefan emphasized the importance of taking risks, maintaining industry connections, and leveraging technology while emphasizing the value of human interaction in their field, particularly in the context of his company's recent acquisition and expansion.  Next steps  Stefan to continue leading Be on Quality through the merger with Volker group.  Be on Quality team to expand services, particularly in AI implementation for medical devices and clinical trial areas.  Stefan to maintain transparent communication with employees regarding company changes and future plans.  Be on Quality to collaborate with sister company Be on Conception in Switzerland on combination products.  Stefan to continue balancing work responsibilities with personal time, including occasional “beach visits”.  Stefan to maintain regular revenue and project load calculations to mitigate fears about project availability.  Stefan to focus on providing value and mentorship to senior consultants and business area leads.  Be on Quality team to continue using AI as a tool to enhance work efficiency without replacing human expertise.  Summary  Journey to Medical Device Consulting  Stefan shared his journey from working in automotive quality management to founding his own medical device consulting company, Be on Quality GmbH, after being encouraged by his mentor. He described how he grew the business through referrals and local connections in Nuremberg, where there are approximately 500 medical device companies. Stefan emphasized that taking risks is essential for growth, particularly when transitioning from freelance work to company ownership, and noted that his supportive wife's encouragement was crucial since he was the first entrepreneur in his family.  Customer Retention Strategies in Medical Devices  Stefan emphasized the importance of maintaining connections and visibility in their industry, highlighting that cold calling and direct knocking do not work effectively. He shared experiences of past customer relationships, including a challenging project where deliverables did not meet the client's expectations, leading to a contract that could not be salvaged. Stefan stressed the need for clear communication and alignment with customer expectations to ensure long-term customer retention, which is crucial in their competitive medical device regulatory market. Monir suggested a mechanism for filtering potential customers with a small initial project to assess compatibility and expectations, which Stefan acknowledged as a useful approach, especially for startups and small companies.  Business Growth and Team Dynamics  Stefan discussed his business challenges, including a difficult working relationship with a former colleague that led to a split, but emphasized that such challenges are part of growing a company. He reflected on how his company, which started in 2017 and began as a freelance business in 2013, has grown to 27 employees, with his team sometimes advising him to focus on organic growth rather than taking on new projects. Stefan noted that while MDR hasn't significantly accelerated his business, he finds working with technology and engineering companies most comfortable, though his team has expertise across various product types.  Client Pricing and Documentation Insights  Stefan and Monir discussed pricing challenges with clients, where Stefan noted that while some clients negotiate prices, none have shown negative emotions about pricing. They also discussed the high costs of notified bodies and the importance of creating high-quality technical documentation to reduce review rounds. Stefan shared his perspective as CEO of Be on Quality, revealing he works approximately 50 hours per week and enjoys his job, though he prefers the concept of office time and home time rather than work-life balance.  AI's Role in Human Work  Stefan shared his professional journey, particularly in housing and installation projects, and expressed concerns about the evolving nature of his role as the company grows. He acknowledged his fear of not being able to provide sufficient mentoring to his colleagues, despite his efforts to maintain a hands-on approach. Stefan also discussed his perspective on artificial intelligence, emphasizing its potential to enhance rather than replace human work, and highlighted the importance of human interaction in their industry. Monir encouraged Stefan to view AI as a tool to assist and inspire, rather than relying on it systematically for all tasks.  Strategic Company Acquisition Success  Stefan discussed the recent acquisition of his company by a larger partner, which he described as a strategic move to expand services and reach. He emphasized that the decision was made after thorough discussions with his team, who supported the merger despite initial concerns about changes. Stefan highlighted the importance of trust and open communication within the company, which he believes contributed to the successful transition. The acquisition has allowed his company to grow and make a bigger impact, with additional resources and expertise from the partner company. 

Medboard: https://www.medboard.com/ EUROPE new eIFU rules - Let's save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en EasyIFU.com   MDR + IVDR + AI Act = MDCG 2025-6 - Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf MDCG 2025-5: IVDR Performance Study - Masterclass to understand Performance Study: https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf Team-NB. Software Qualification (IVDR) clarification - Translation of the MDCG 2019-11: https://www.team-nb.org/wp-content/uploads/2025/06/Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627.pdf MDCG 2019-11: https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf   CECP: Mechanical Respiratory - Result is not good: https://health.ec.europa.eu/document/download/80f2432d-a9da-48ae-8ebb-0054b4922033_en?filename=cecp-2025-0000232089_opinion_en.pdf MDCG 2025-4 Software delivered with Online Platforms - Are your apps conform: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7-b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf PROJECT NAME: COMBINE - Clinical Trials with Medicine and IVDs: https://ec.europa.eu/newsroom/sante/newsletter-archives/64447 https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies/combine-project-1-pilot-all-one-coordinated-assessment_en UK UK PMS mandatory since June 16th, 2025 - Learning starts: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements#full-publication-update-history Press Release: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain Periodic Safety Update Report: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur Example of reportable incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents MORE Guide update: https://assets.publishing.service.gov.uk/media/6847fc9c944a600f13bcb852/User_Reference_Guide___MORE_Incident_Submissions.pdf Document for implementation of Data: https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations   ROW USA UDI for combination products - What are the rules?: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-requirements-combination-productsConducting Remote Reg Assessment - SQuestion and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers  Transfer of Premarket Notification (510k) - Questions & Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transfer-premarket-notification-510k-clearance-questions-and-answers   CANADA Canada is cancelling all MDELs - Only if you don't confirm the Annual License Review: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/cancellation-non-compliance-annual-review-requirements-2025.html   Saudi Arabia SFDA Webinar: Risk Management File - July 8th, 2025 10 AM Saudi Time: https://www.sfda.gov.sa/en/workshop/3868398 Podcast Episode 340 - Software as a Medical Device: Beginner's guide to Testing and Validation: https://podcast.easymedicaldevice.com/340-2/ Episode 341 - Notified Bodies raise concern on Risk Grading: https://podcast.easymedicaldevice.com/341-2/ Episode 342: From Zero to One: SaaS Founder's First Five Years: https://podcast.easymedicaldevice.com/342-2/

From Zero to One: SaaS Founder's First Five Years with Ivan Perez Chamorro 🎧💡 In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the CEO and founder of Medboard, a fast-growing SaaS company. Ivan takes us behind the scenes of his entrepreneurial journey, from starting with zero to building a thriving business in the tech world. 🚀 In this candid conversation, Ivan dives into: The story behind Medboard and how it all began from scratch 🛠️ The challenges he faced along the way and how he successfully scaled the business 📈 The lessons learned and the things he would do differently if given a second chance 🤔 A day in the life of a CEO: How many hours does Ivan work? How does he disconnect? 🤯 The personal fears and struggles that come with being a founder, and how to overcome them 😬 And of course, what’s next for Medboard—the exciting plans ahead! 🔮 This episode offers an honest, no-holds-barred look at the journey of building a successful SaaS company and what it takes to lead with passion, persistence, and resilience. Don't miss this insightful discussion! Tune in now and hear firsthand what it takes to take a business from zero to one. Listen to the full episode here: Medboard Social Media to follow ivan-perez-chamorro linkedin: https://www.linkedin.com/in/ivan-perez-chamorro/ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does 🩺 Risk Management mistakes that could cost you your certification! In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi tackles one of the most common and preventable Notified Body non-conformities: flawed risk grading strategies. If your team is still using overcomplicated matrices or adjusting severity post-mitigation — this episode is your wake-up call. 🎯 What you'll learn: The most frequent audit findings related to risk grading Real-world case studies showing where manufacturers got it wrong A clear step-by-step guide to build a compliant and logical matrix How to use ISO 14971 & ISO/TR 24971 correctly Why severity should NEVER be downgraded after controls 🔧 We’ll also cover: How to scale your matrix by device class Common pitfalls to avoid How to align QA, RA, clinical, and engineering teams How Easy Medical Device can help you fix or build your Risk Management system ✅ Whether you're in Regulatory Affairs, Quality Assurance, R&D, or Clinical, this episode will give you concrete tools to strengthen your risk files and pass your audits with confidence. 📌 Watch now and share it with your team! 📞 Need help? Contact Easy Medical Device to review or improve your Risk Management File. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

■Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cover: ►Why testing matters: Real-world examples of what can go wrong (and how to avoid it) ►From user needs to test cases: Simple “if-then” steps you can try today ►Who should test: Pros and cons of in-house vs. external testers ►eQMS basics: How to validate your electronic Quality Management System with minimal hassle ►Quick tips: The one thing you must do first, and the top beginner pitfall to avoid Whether you’re a developer, QA engineer, or healthcare innovator, you’ll walk away with practical strategies to ensure your medical software is safe, reliable, and compliant. Tune in and make your next SaMD project a success! ► Links from the Video ■Anindya Mookerjea:  https://www.linkedin.com/in/anindyamookerjea ■S-Cube Technologies: https://eqms-smarteye.com/ ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice

Europe Notified Body survey report - 31 October 2024 - What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf The MIR form has been updated - Version 7.3.1 - Don't use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en   UK: UK MIR and FSCA - Change is in the AIR: https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide UK MDR 2002 is dying - Long life to UK MDR 2025: https://www.legislation.gov.uk/ukdsi/2025/9780348269529 : Real-World Data or Clinical Trial or Both?- This is the question: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions     Training EU MDR Green Belt June 2025 - June 23rd, June 27th: https://school.easymedicaldevice.com/course/gb34/ eTraining on Vigilance and Audit preparation - Self-paced: https://school.easymedicaldevice.com/emd-course   ROW USA Q-Sub update  - New electronic template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-q-submissions   Brazil: SIUD or UDI in Brazil - Manual of Use in Portuguese: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/manual_siud_v01.pdf   Saudi Arabia: Series of Webinar - June is a Busy month in Saudi Arabia: 16 June 2025 Companion Diagnostic Regulatory Requirements: https://www.sfda.gov.sa/en/workshop/3540492 17 June 2025 Saudi Unique Device Identification (SAUDI-DI): https://www.sfda.gov.sa/en/workshop/3540493 19 June 2025 Artificial Intelligence and Machine Learning: https://www.sfda.gov.sa/en/workshop/3540495 23 June 2025 Digital Health Medical Devices regulatory approach: https://www.sfda.gov.sa/en/workshop/3540496 24 June 2025 Medical Devices Risk Classification: https://www.sfda.gov.sa/en/workshop/3540497 Saudi In-house Devices - Not like EU: https://www.sfda.gov.sa/sites/default/files/2025-05/MDS-G022En.pdf   Turkey: In Turkey, Economic Operators are Liable - Even after discontinuation or temporary stop of supply: https://titck.gov.tr/duyuru/tibbi-cihazlarin-tedarikinin-kesintiye-ugramasi-veya-durdurulmasi-sona-ermesi-durumunda-i-ktisadi-i-sletmecilerin-yukumlulukleri-hakkinda-duyuru-21052025113350   PODCAST: Podcast Nostalgia - What happened in May 2025 Episode 334 - What is the new UK Post-Market Surveillance Requirements? With Claire Dyson: https://podcast.easymedicaldevice.com/334-2/ Episode 335 - When is Regulatory Affairs needed during Design? With Aouda Ouzza: https://podcast.easymedicaldevice.com/335-2/ Episode 336 - is EHDS dangerous for Medical Device Manufacturers? With Cecile van der Heijden: https://podcast.easymedicaldevice.com/336-2/ Episode 337 - How Deepeye Medical overcame the AI Act? With Carmen Bellebna; https://podcast.easymedicaldevice.com/337-2/ Episode 338 - Trapped or Strategic? Changing Notified Bodies During MDR transition: https://podcast.easymedicaldevice.com/338-2/  

Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Linkedin Post: https://www.linkedin.com/feed/update/urn:li:activity:7331974765156384769/  Team NB position paper transfer agreement: https://www.team-nb.org/wp-content/uploads/2025/01/Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions.pdf  MDCG 2022-4: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-4_en.pdf  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.  Who is Carmen Bellebna?  Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye’s QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/