MDR 745/2017 Internal Auditor
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Course description
An Internal Auditor training course focused on the European Medical Device Regulation (MDR 745/2017), integrating the requirements of Annex I (GSPR), Annexes II and III (technical documentation), Annex XIV (clinical evaluation and PMCF), and the role of European competent authorities and notified bodies.
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Course objective
Prepare internal auditors to assess QMS and technical documentation compliance with MDR 745/2017, identifying gaps and preparing the organisation for external audits by European notified bodies.
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Course programme
- 01
Overview of MDR 745/2017 and the transition from the MDD
- 02
Risk classification under Annex VIII
- 03
GSPR, General Safety and Performance Requirements
- 04
Technical documentation (Annexes II and III)
- 05
Clinical evaluation and PMCF (Annex XIV)
- 06
Post-market surveillance and PSUR
- 07
Preparing for a Notified Body audit
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Who can attend?
- Internal auditors, Regulatory Affairs, Quality and Clinical Research professionals, and consultants involved in CE marking projects under MDR 745/2017.
Certification
HSC Global Certificate Recognised by Exemplar Global RTP
Internationally recognised in more than 30 countries by Exemplar Global, with independent validation of the professional's technical competence.
Instructor
Mariana Barreira
- Mariana Barreira
- Exemplar Global-certified MDSAP Lead Auditor, with more than 8 years' experience implementing ISO 13485 QMS and working across the programme's 5 countries.
- Exemplar Global-certified MDSAP Lead Auditor
- Experience across the programme's 5 countries
- Specialist in ISO 13485 QMS implementation
- Specialist in the European MDR 745/2017 Regulation
- More than 8 years' experience