Advamed Posts

Mobile Medical Apps and EQMS: The Latest Buzz

Mobile Medical Apps and EQMS: The Latest Buzz

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

I attended my first AdvaMed MedTech Conference in early October, and it was an awesome opportunity to interact and learn from the industry. There were many things I learned about the medical device industry, but one thing that really stood out for me was a session on mobile medical apps. (more…)

New FDA Deal on Medical Device User Fees

Mark Crawford

In early February, the FDA and representatives from the medical device industry (Advanced Medical Technology Association, Medical Device Manufacturers Association, Medical Imaging and Technology Alliance) reached an agreement on recommendations for the third reauthorization of the Medical Device User Fee and Modernization Act. (more…)

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process. (more…)