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Totex Nears Completion of ISO 13485:2003 Quality Management System Requirements for Medical Devices
TORRANCE, California, March 2, 2009 — Totex Manufacturing, Inc., a leading manufacturer of custom battery and charging solutions, today announced plans for completion of ISO 13485:2003. This standard governs the design and production of medical devices and sets forth requirements for a comprehensive management system.
While ISO 13485 outlines compliance for many specific types of medical devices, those involving power and charging devices include:
- Responsibility in promotion of regulatory requirements, such as 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States
- Controls in work environment to ensure product safety
- Risk management and design transfer activities during product development
- Corrective and preventative actions verification
Final audit for compliance will be on May 9th, 2009. "We are excited to add ISO 13485:2003 compliance to our long list of current quality procedures. Completion will give our medical customers further confidence in our already high quality and safety standards," said Tommy Tong, owner of Totex.
About Totex Manufacturing, Inc.
With US headquarters in Torrance, California, Totex delivers quality battery and power management solutions to medical and military OEMs as well as the consumer electronic market. In-house engineering for design and prototyping combined with state-of-the-art local and overseas ISO 9001:2000 production facilities makes Totex ideal for custom power projects of all sizes.