CIMS services within the Medical Device Regulation
- QMS development
- Audit
- 3rd party assessment
- Technical File development
- Authorised representative build
- Documentation management
- Data Management
- Vigilances
- MDR conformity assessment
- Heath Authorities communication
- CE Marking
- Clinical Development
- PMCF
- Evaluation
- Investigation
- Data Management
- CRO Management
Services post CE-marking
- GCP storage of MD files, documents data
- End market storage(10, 15 years)
- Data Management services
- Post Marked
- Regulatory compliances
- Acting Authorised representative
- Post-market
- Surveillance
- Vigilances
- Market surveillance
- PMCF
- PSUR
- Statistical services