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
Veranex
What previous participants said
Contact
Select date
26.10.202626 October 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
19.10.2026
Latest Cancellation
04.10.2026
View Program
Terms
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
Do You Have a Specific Competency Need?
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
Academy News
Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.