August 30, 2017

MHRA launches an introductory guide to the MDR and IVDR regulations

Manufacturers need to demonstrate that their medical device meets the requirements in the MDR or IVDR by carrying out a conformity assessment. The assessment route depends on the classification of the device. Read the full document here

August 30, 2017

PRESS RELEASE: UL Announces GREENGUARD Certification for Medical Devices in Breathing Gas Pathways

UL Environment, a division of UL (Underwriters Laboratories Inc.), a global safety science leader, announced today it has launched GREENGUARD Certification for Medical Devices in Breathing Gas Pathways. Read the press release here.

August 28, 2017

PRESS RELEASE: UL Becomes Recognized Auditing Organization Under Medical Device Single Audit Program

The program allows medical device manufacturers to meet quality management system requirements for multiple geographies in one audit. Read the press release here

August 28, 2017

PRESS RELEASE: U.S. FDA Recognizes UL 2900 for Use in Premarket Reviews

June 9, 2017

FDA Reveals list of Devices Requiring Reprocessing Validation