News

20 Apr

The new Standard was published on March 15th, 2018, after a long gestation period (the initial Work Proposal for the Standard was issued in June 2013). Thankfully, for those of us involved in implementing and maintaining an OH&S Management System (OHSMS) there are few surprises….

20 Apr

In addition to a new Standard in 2016 and the MDR/IVDR regulations in 2017, we note other changes afoot that will affect Medical Device Manufacturers, Component Suppliers to Medical Device Manufacturers……

24 Sep

BQAI Information Security Management Systems accreditation now includes Printing, Electrical, IT and other services…..

23 Sep

Notified Bodies will not always be required for Medical Device CE Marking………