Technical Documentation
- Complete Technical File assembly per EU MDR Annex II & III.
- Device description and specifications.
- Design and manufacturing information.
- General Safety and Performance Requirements (GSPR) checklist.
- Benefit-risk analysis documentation.
Quality Management System
- ISO 13485:2016 implementation support.
- QMS documentation development
- Notified Body audit preparation.
- Process validation documentation.
Clinical Evaluation
- Clinical Evaluation Plan (CEP) development.
- Clinical Evaluation Report (CER) writing.
- Literature search and review.
- Clinical data analysis and synthesis.
- Post-Market Clinical Follow-up (PMCF) planning.
Risk Management
- Complete Risk Management file per ISO 14971.
- Risk Analysis, evaluation, and control documentation.
- Risk management plan and report.
- Residual risk assessment and benefit-risk determination.
Post-Market Surveillance
- Post-Market Surveillance Plan development.
- Periodic Safety Update Report (PSUR) preparation.
- Vigilance reporting systems.
- Market surveillance and competitor monitoring.