From Zero to One: Becoming a Medical Device auditor
Description
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.