Medical Device and Pharmaceutical manufacturers are a major focus for our consulting practice. Gateway has been frequently engaged to develop information management strategies to improve the efficiency and effectiveness of business processes in FDA regulated industries. Gateway’s information technology professionals are highly qualified to implement electronic document management solutions in support of the applicable ISO standards and FDA regulations:
- ISO 13485 – Medical Device Quality Management Standard
- 21 CFR Part 11 Electronic Records; Electronic Signatures
- 21 CFR Part 820 Quality System Regulation:
- Design Controls: Requirements, Design History Files (DHF)
- Traceability: Device History Record (DHR)
- Corrective & Preventive Action (CAPA)
- Device Master Record (DMR)
- Verification & Validation
Gateway has extensive experience in providing the documented evidence required by medical device manufacturers to comply with both the technical and procedural aspects of the FDA 21 CFR Part 11 and 21 CFR Part 820. including reports for:
