Our Approach for Medical Devices System Software
Validation (ISO 13485)
- Validation Master Plan (One Time)
- Gap Assessmet (GAP)
- Initial Risk Assessment (IRA)
- 21CFR Part 11 compliance services (Where ever applicable)
- User Requirement Specification (URS) If Required
- Validation Plan (VP) Qualification Protocol Preparation and execution.
- Functional Specification (FS) If Required
- Design Specification (DS)If Required
- Functional Risk Assessment Document (RA)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrix (TM)
- Validation Summary Report (VSR)
