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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Happy Holidays

Happy Holidays 2021

Wishing you all the best during this Holiday season and a prosperous New Year. Aaron Joseph Streamlined Compliance for Medical Device Development Sunstone Pilot, Inc. sunstonepilot.com