How the FDA Defines and Evaluates Medical Device Biocompatibility
Biocompatibility testing is the best way to evaluate medical device safety. Through biocompatibility testing, the FDA confirms that either there are none […]
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 Pilot Production Phase is the beginning of the end of product development. Pilot Production is just a step away from contract […]
Prototype testing provides a cost-effective method for ensuring products meet user requirements and regulations. Simple proof of concept tests can predict future […]
Brainstorming can be a fun exercise to solve a particular problem or expand on an idea. As an inventor, you probably already […]
No matter what your product is, the end goal is to make it to production. Make sure your product is ready by […]
The challenge Fixtures are used in product development and manufacturing for a variety of purposes. Most commonly they are used as a […]
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