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01
Course description
The MDSAP Internal Auditor course covers ISO 13485:2016, the MDSAP Audit Approach and the changes in ISO 19011:2026. Contact the HSC team to confirm duration, format, dates and fees.
02
Course objective
Enable participants to conduct MDSAP internal audits, preparing the organisation for external audits by Auditing Organizations (AOs) and ensuring effective integration between ISO 13485 and additional regulatory requirements.
03
Who can attend?
- Internal auditors, Quality and Regulatory Affairs professionals, Technical Managers and prospective auditors at companies operating or intending to operate within the MDSAP scope.
Certification
HSC Global Certificate
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 QMS implementation under the European MDR 745/2017 Regulation
- More than 8 years' experience