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…
What You Need to Know About Risk Management and Using Post-Market DataWhat you do with the data you collect is critical
Tue, 04/17/2018 - 11:23
The aim for any medical device company is always to ensure that the devices they make are safe and effective. How do you ensure that those devices remain both effective and safe once on the market? One key way is through implementing post-market…