Verification and validation are design controls required by the FDA to ensure the medical devices you manufacture are safe, effective, and fit
FMEA stands for Failure Mode and Effects Analysis and is a risk management tool for identifying potential failures. FMEA assesses the severity
Biocompatibility testing is the best way to evaluate medical device safety. Through biocompatibility testing, the FDA confirms that either there are none
Listed within the FDA’s 21 CFR 820 are detailed regulations governing medical device records and quality systems. These regulations identify five record
21 CFR Part 820 is a set of FDA regulations that govern medical device quality systems. Detailed within are current good manufacturing practice
Part of the Medical Device Regulation Act involved establishing specific regulatory controls for each of the three classes of medical devices. The
In 1971 a new IUD called the Dalken Shield entered the market and was implanted in almost 3 million women in the
The FDA outlines specific requirements for developing a medical device. These requirements necessitate a product development process conducted in progressive stages. This
Need help developing an ISO compliant QMS? Speak with one of our experts and get answers to all your project questions. Contact
Need help classifying your medical device? Speak with one of our experts and get answers to all your project questions. Contact Us
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