Risk Management File (ISO 14971)
- Risk Management plan development.
- Hazard identification and Risk Analysis.
- Risk control measures documentation.
- Overall residual risk evaluation.
- Complete risk management report.
Device Master File (DMF) & Plant Master File (PMF)
- Comprehensive DMF assembly for CDSCO.
- Manufacturing process documentation.
- Quality control procedures.
- Facility and equipment information.
- Supplier and material controls.
Essential Principles/GSPR Checklist
- Master compliance checklist for every Essential Requirement and GSPR.
- Requirement-by-requirement compliance justification.
- Evidence mapping and traceability.
- Harmonized standards compliance documentation.
Clinical Evaluation Report (CER)
- Clinical evaluation strategy development.
- Systematic literature review and analysis.
- Clinical data evaluation and synthesis.
- CER writing per MEDDEV 2.7/1 rev 4 and EU MDR requirements.
- PMCF planning and evaluation.
Biocompatibility Documentation
- Biological Evaluation planning per ISO 10993-1.
- Material characterization and chemical analysis.
- Test strategy development and lab coordination.
- Biological Evaluation report writing.
Sterilization Validation Documentation
- Sterilization validation protocol development.
- IQ/OQ/PQ documentation assembly.
- Sterility assurance level (SAL) validation.
- Final validation report preparation.