- Design controls
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Design Controls designates the application of a formal methodology to the conduct of product activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. Medical devices).
Medical devices
The Food and Drug Administration (FDA) requires that medical device manufacturers who want to market certain types of medical device in the USA follows the Design Control requirements formulated in 1996, Design Controls (21 CFR 820.30).
The Medical devices directive similarly lists several requirements regarding the design of a medical device.
ISO 13485 contains section 7.3 Design and Development which specify what procedures have to be put in place by manufacturers.
The objective of Design Controls, in this context, is to guarantee manufacturers follow a methodologically-sound process to develop a medical device, which in turns ensures, or at least improves the probability, that the device will reach an acceptable level of efficacy and safety.
References and external links
- 21 CFR 820.30 on the FDA website [1]
Categories:- Design
- Food and Drug Administration
- Medical Devices regulations
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