- New Regulations (EU) 2017/745 and 2017/746
- ISO 13485
- Implementation of harmonized standards
- New UDI system
- Requirements for clinical trials for medical devices
- Reporting to Eudamed
- Classification rules
- Requirements for technical documentation and preparation
- Post-market surveillance and vigilance system
- Risk management
- Obtaining CE certificates
- Provide you with a person responsible for regulatory compliance (PRRC)