More Notified Bodies Give Up on EU MDR/IVD Certification
The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t be offering certification. Read More
Devicemakers Comment on FDA’s Approach to Machine Learning for SaMD
A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software… Read More
Devices News
EU Committee Sounds Heightened Alarm on Shortage of Notified Bodies
With less than one year before the EU’s Medical Device Regulation takes effect, an industry group is raising increasing alarm about the lack of “essential guidance” and the shortage of notified bodies needed to certify products in compli... Read More
FDA Finds Weak Process Controls at Anesthesia Associates
A March 11-14 inspection of Anesthesia Associates’ San Marcos, California facility revealed inadequate process control procedures. Read More
International Hospital Products Cited for Numerous QMS Failures
Process validation failures, documentation lapses and failure to establish corrective and preventive actions were just a few of the quality lapses found during a March 15-19 inspection of International Hospital Products’ Littleton, Color... Read More
Cosmetic Devicemaker Fails to Submit MDRs on Time
The FDA cited Carol Cole Company for failure to submit timely medical device reports of its devices that use microcurrents to tone, firm and reduce wrinkles, according to a Form 483 that was issued following a March 20-22 inspection of t... Read More
