Listed within the FDA’s 21 CFR 820 are detailed regulations governing medical device records and quality systems. These regulations identify five record types that medical device manufacturers need to maintain. These include the Design History
21 CFR Part 820 is a set of FDA regulations that govern medical device quality systems. Detailed within are current good manufacturing practice (cGMP) requirements ensuring medical devices distributed within the United States are effective, safe,
Part of the Medical Device Regulation Act involved establishing specific regulatory controls for each of the three classes of medical devices. The higher the class of device, the more risk associated with it, and the
In 1971 a new IUD called the Dalken Shield entered the market and was implanted in almost 3 million women in the United States. Over the next few years, the CDC noted a disproportionate number
The FDA outlines specific requirements for developing a medical device. These requirements necessitate a product development process conducted in progressive stages. This rigor ensures that risk and device effectiveness are reviewed and documented at each
Need help developing an ISO compliant QMS? Speak with one of our experts and get answers to all your project questions. Contact Us About Synectic Product Development: Synectic Product Development is an ISO 13485 certified, full-scale product
Need help classifying your medical device? Speak with one of our experts and get answers to all your project questions. Contact Us About Synectic Product Development: Synectic Product Development is an ISO 13485 certified, full-scale product development
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