A Quality System Registration Service
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Current Good Manufacturing Practices (CGMP)
- Manufacturers of medical devices that plan to distribute products in the U.S. are required to adhere to Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP), under which the company must establish a quality assurance program and its medical devices must meet specifications and controls to guarantee they are safe and effective for intended use."
- CGMP covers quality assurance programs and organization, buildings, equipment, components, production and process controls, packaging and label control, distribution and installation, device evaluation and records.
- The FDA monitors medical device problem data and inspects the operations and records of device manufacturers to determine CGMP quality assurance compliance.
- These standards can be ordered through ANSI at 212-642-4900 and www.ansi.org.