![]() Under a robust design controls process, the initial device that was intended to be designed should match the final design without any variation (unless documented).ĭesign controls processes must be completed according to the requirements outlined in the FDA’s 21 CFR Part 820.30 and ISO 13485:2016. Design Controls refer to actions taken by a manufacturer to control the design and development of a new medical device. ![]() Prior to starting development, manufacturers must develop a design controls process. ![]() The documentation that comes out of design control procedures is collectively called the “Design History File” or DHF. What is a Design History File?Ī DHF is a record of all the actions and steps involved in designing a medical device. Proper documentation is vital to organization, and, during the product design phase, that means creating and maintaining your Design History File (DHF). If your team isn't organized, you risk hurting product quality, not passing an audit and slowing production. One of the most important things a medical device company can do to help bring products to market quickly is to stay organized.
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