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 manager for Abbott, clarified a few points about design inputs in “Developing Design Requirements to Ensure User Needs Are Met in Product Development” on February 7.
A design input is defined as the “physical and performance requirements of a device that are used as a basis for device design,” according to 21 CFR Part 820.3.
Writing design input...