Medical DevicesMedical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products.
Certification to ISO 13485 offers a major competitive edge for medical device companies. Far-sighted firms are planning either for first-time registration to ISO 13485:2003, or an upgrade from ISO 13485/8:1996.Your consultant should have extensive work experience in the Medical device manufacturing industry. Look for the expert
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| Aerospace
AS9100, AS9110, AS9120 Quality Mgmt. ISO 9001 Medical Devices ISO 13485 Environmental ISO 14001
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"I have worked with Chris Atherton since 1987. Chris developed the quality program and we continue to enjoy an excellent quality performance to this day. Chris was very instrumental in the integration of our Quality System into the Fairchild global Quality System. Chris has a great deal of experience in the processes required to successfully support the aerospace and defense markets." Kevin Casey |
