
- The approval process for medical devices for the US market and the UDI.
- Registration of medical devices for Canada
- FT for the international market: STED, TOC, EU MDR 745/2017
- The new EU MDR 2017/745 for Medical Devices
- The new EU MDR 2017/746 for IVDs
- Risk management: requirements, methods and solutions for compliance with ISO 14971
- Software validation for medical devices according to IEC 62304
- Software validation for regulated processes, practical examples of validation of SW ERP and Excel files
- Standard ISO 13485:2016: news and practical solutions for the application of the requirements
- MDSAP (Medical Device Single Audit program) for access to the US, CANADIAN, BRAZILIAN, JAPANESE and AUSTRALIAN markets
- Process validation: Basic concepts (IQ, OQ, PQ), validation protocols and reports and practical examples of the most common processes
- Etc..