MDR Auditing – Training of Internal Auditors in Relation to MDR
Gain knowledge about the MDR requirements not covered by ISO 13485 and understand the MDR requirements related to the QMS and their impact. Learn what to look for when auditing a QMS against the MDR requirements.
Course objective and outcome
The following skills and competences are developed:
- Knowledge about the MDR requirements not covered by ISO 13485
- Understand the MDR requirements related to the QMS and their impact
- What to look for when auditing a QMS against the MDR requirements
Content
- Risk Management
- Unique Device Identifier & EUDAMED
- Person responsible for regulatory compliance
- Liability
- Registration of economic operators & obligations (EU Rep, Distributors, Importers)
- Regulatory compliance requirements including conformity assessment
- Post Market Surveillance process
- Vigilance
- Clinical Investigation and evaluation process
Who should attend
- Quality Managers
- Person responsible for implementation of MDR requirements into the QMS
- Responsible persons performing internal & supplier audits
Trainer
Michael Maier
Advisor and Lead Auditor, MMEX GmbH
Michael Maier is an experienced lead auditor specialising in medical device quality management systems and regulatory compliance. On this course, he helps participants identify and audit the MDR requirements that extend beyond ISO 13485, including requirements related to economic operators, risk management, clinical evaluation, post-market surveillance, vigilance, UDI and regulatory compliance. Drawing on his auditing experience across MDR, MDSAP, ISO 13485 and US quality system requirements, he provides practical guidance on preparing, conducting and documenting effective internal and supplier audits.
What previous participants said
Contact
Select date
26 October 20264 March 2027
25 October 2027
26 October 2026 - at 09:00 - 17:10
Price ex. VATLatest Registration
19 October 2026
Latest Cancellation
4 October 2026
View Program
Terms
In-house Courses
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We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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