EU Medical Device Regulation QMS Lead Auditor Practitioner (Classroom & Asynchronous)
About This Course
This intermediate-level course is designed for professionals in the medical device industry seeking to deepen their expertise in regulatory compliance and quality auditing. Learners will gain practical skills to audit QMS against EU MDR requirements, apply ISO 14971 risk management principles, and prepare CE marking documentation. The course addresses critical industry needs such as regulatory alignment, risk mitigation, and market access readiness. Ideal for RA, QA, and QM professionals, it supports career advancement in regulatory affairs, quality assurance, and medical device manufacturing by enhancing audit capabilities and compliance knowledge.
What You'll Learn
* Understand the regulatory landscape of EU MDR and ISO standards.
* Apply risk management principles across the medical device lifecycle.
* Classify medical devices and interpret General Safety and Performance Requirements (GSPRs).
* Conduct effective QMS audits and report nonconformities.
* Prepare technical documentation and implement post-market surveillance (PMS) and vigilance activities.
Course Modules Include:
* Introduction to EU MDR and ISO Standards
* Risk Management for Medical Devices (ISO 14971)
* EU MDR Compliance Framework
* QMS Auditing for EU MDR
* Implementation of MDR for CE Marking
Entry Requirements
• Completed the BSI's ISO 13485 Lead Auditor Practitioner courses.
• Aged 21 and above;
• Have minimum GCE “N”, “O,” or “A” Level / NITEC or a diploma qualification and minimum 1 year of working experience; and
• Have an English language proficiency equivalent or higher of any of the following: GCSE N/O Levels pass in English