Services in the field of medical devices
Our services include:
Regulatory Affairs / Quality Management / Vigilance
- Feasibility assessment, medical device classification
- Compilation of technical documentation
- Risk management in accordance with EN ISO 14971
- Conformity assessment procedures
- Set-up and implementation of quality management systems (ISO 13485)
- Audits
- Vigilance relating to medical devices
- Control of the promotional material considering the legal framework