Medical Device Development

What Are Medical Device Design Controls?

Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully …

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Get a Grip on Medical Device Development

Or the 5 Types of Knowledge needed for successful Medical Device development Developing innovative new products is hard but developing innovative new medical devices is even harder. That’s because while both involve a great deal of knowledge, medical device development requires even more knowledge and across a broader range of domains.   Some engineers assume …

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