Medical Devices

ADVANCED QUALITY ENGINEERING (AQE)

US FDA QSR 21 CFR 820, ISO 13485:2003 CONSULTING

MEDICAL DEVICE COMPANIES

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 (1996 & 2003) for all types of medical products.

Area's of expertise for Medical Device Companies

	Application of the US FDA QSR & 21 CFR 820 to all types of medical devices.
	Application of ISO 13485:1996 and 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

E-Mail Us: dale.mize@quality-inc.com