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View all our technical, regulatory and normative information including guides, webinars, news…
- Technical Documentation per (EU) Medical Devices Regulation 2017/745
- European in Vitro Diagnostic Devices Regulation (EU) 2017/746
- Post Market Surveillance and Vigilance New Requirements under the European Medical Device Regulations
- The Clinical Evaluation Requirements (CER) under the EU MDR 2017/745
- Risk management applied to Medical Devices (ISO 14971:2019)
- Medical Device Single Audit Program (MDSAP) for Manufacturers
- ISO 13485:2016 Requirements
- European Medical Devices Regulation (EU) 2017/745
- Medical Device Electrical Safety – A Review of IEC 60601-1/A2