Faulty Seal Blamed for Sterlimed Agilis Recall
FDA has identified the recall as a Class I, the most serious type of medical device recall.
Philips Forced to Stop Making AEDs Until Problems are Fixed
FDA and Philips reached an agreement regarding manufacturing issues involving the company’s automatic external defibrillators.
Medtronic Exec: How to Move Past Compliance to Quality
The medical device industry has had a tough time recently when it comes to its reputation for addressing defects.
IQ, OQ and PQ: The Backbone of Your Quality System
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
The Necessary Overhead of Quality Processes in Medical Device Product Development
The Necessary Overhead of Quality Processes in Medical Device Product Development
Why Is Quality Focusing on Compliance?
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
What if FDA and Medtech Worked Together on Quality?
An FDA initiative, now in its pilot phase, is helping the agency and medical device manufacturers see quality assurance in a new light.
