Content by Alex Morris, Jon Speer
Top Three Document Management Tips for Medical Device CompaniesAvoid the headache (and citations) by establishing electronic document control
Wed, 07/08/2015 - 12:00
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation.
We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to… Eight Questions That Define Your Medical Device User NeedsDon’t start with what the device does; start with who it’s for
Tue, 04/21/2015 - 13:20
When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet…