US FDA QSR 21 CFR 820, ISO 13485:2003 Consulting
Contract consulting for medical device companies
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Utilize the AQE staff's deep experience in the implementation of the US FDA Quality System Regulation (21 CFR 820), and ISO 13485 (2003) for all types of medical products.
Areas of expertise for Medical Device Companies
- Application of the US FDA QSR & 21 CFR 820 to all types of medical devices.
- Application of ISO 13485:2003 to all types of medical devices.
- Sterilization of medical devices, EtO, Gamma to international Standards (ANSI/AAMI/ISO 11135/11137)
- Staff training in medical device regulations.
- Fully compliant medical device quality system creation and implementation.
Email us: dale.mize@quality-inc.com
| Expertise in compliant medical device quality systems in the key areas of:
- The management culture & quality processes
- Design Control systems
- Internal auditing systems
- Corrective & Preventive Action systems
- Documentation & record systems
- Management review
- Process and equipment validation & control systems (IQ / OQ)
- Sealing process development & validation (pouches & trays)
- Calibration & Maintenance systems
- Quality Manual creation including all procedures and work instructions
- Training & resource systems
- Purchasing & supplier control systems
- Identification & Traceability systems
- Non-conforming material control systems
- Labeling & packaging control systems
- Handling, storage, preservation, distribution & installation systems
- Statistical techniques and systems
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