Putting the ‘Management’ into Quality Management System
Three ways to demonstrate management oversight within your QMS.
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.
Here’s Something for Zimmer Investors to Chew On
According to a Wall Street Journal report, Zimmer Biomet is considering a sale of its dental unit.
Varian to Acquire Embattled Sirtex for $1.3B
Sirtex, which specializes in interventional oncology, suffered numerous setbacks in 2017, including the firing of its CEO and disappointing clinical trial results.
5 Ways Cyber-Physical Systems are Transforming Manufacturing
Dr. James Truchard believes that cyber-physical systems (CPS) are ushering in the next industrial revolution.
A Brief Introduction to Medical Device Biocompatibility
Biocompatibility of medical devices is a complex and evolving subject. Here’s what you need to know.
How Much Should Device Designers Really Know about Micro-Coaxial or Twin-Axial Cables?
Answer: The more device designers know, the better.
