US FDA QSR 21 CFR 820, ISO 13485:2003 Consulting
Contract consulting for medical device companies
|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
Email us: firstname.lastname@example.org
- 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.
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