Good morning all, i trust you are doing well. I just wanted to find out more about what goes into the following documents for CE:
1. Use Specification (Intended Use Statement)
2. MDR compliance summary
3. General Safety and Performance Requirements (GSPR)
4. GDPR compliance summary
1. Use Specification (Intended Use Statement)
2. MDR compliance summary
3. General Safety and Performance Requirements (GSPR)
4. GDPR compliance summary