Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design ...

An R&D manager shares his perspective. Medical device designers are well versed in design controls, but generating design requirements can get a little confusing. At MD&M West 2017, Li Jin, R&D ...

Designed to address the needs of users and patients. Designed to meet inputs and requirements. Proven to meet applicable standards. Meets performance criteria. Realize Design Controls and Risk ...

The design of a switching power supply has always been considered a blend of magic and art by every engineer that designs one for the first time. Fortunately, today the market offers different tools ...

If you are developing a medical device for the U.S. market, you first need to determine how your device will be classified by FDA. If you do not know the FDA classification, I recommend you go check ...