If you are in the medical device industry, either as an inventor, developer, or manufacturer, and you are planning to market in the US, reviewing FDA warning letters should be part of your weekly if not daily routine. You will … Continued
Feb
28
28
Monthly Archives for
February 2012
Feb
24
24
Working as a Consultant with Different Business Cultures in Medical Device Development
A company’s culture is directly related to the number of individuals that have real input into the decision making process of the business. Some large companies run like start-ups, complete with all the chaos, energy and confusion that normally accompanies … Continued
Feb
7
7
Recommended FDA report: “Understanding Barriers to Medical Device Quality”
Recently, I read an FDA report entitled “Understanding Barriers to Medical Device Quality”, which examines the current quality status of medical devices. This informative report compiles the serious adverse events recorded in FDA’s Manufacturer and Used Facility Device Experience (MAUDE) databases, … Continued