Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.

In this podcast episode, we explore:

🔹 What is a Lead Auditor?

The responsibilities, authority, and role differences between internal audits, supplier audits, and certification audits.

🔹 Who can become a Lead Auditor?

The competencies required, background expectations, and what makes a good auditor.

🔹 What you must learn to be effective:

ISO 19011 — the core auditing guideline

ISO 13485 — the medical device QMS standard

ISO 14971 — risk management for medical devices

Software lifecycle & technical documentation considerations

🔹 Do Lead Auditor certificates expire?

Clarifying the myth around renewal, competency maintenance, and the expectations of certification bodies.

🔹 Spotlight: Lead Auditor Training by Medical Device Academy

We review the upcoming training course, covering:

Curriculum and learning objectives

Exam format

Prerequisites

Pricing

Training dates

Certificate details

👉 Learn more or register here: https://medicaldeviceacademy.com/lead-auditor-training/

This episode is ideal for QA/RA specialists, QMS managers, consultants, and anyone aiming to take a leadership role in medical device auditing.

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