Current Headlines

18 Jul

ISO 19011:2018, Guidelines for auditing management systems, has been technically revised and now replaces the 2011 edition……

26 Jun

Many organisations are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits and the like relating to ISO 13485 certification. It is not as difficult as you may think and you could be losing out on high margin business….

25 Apr

The General Data Protection Regulation (GDPR) is a new EU regulation which came into effect on 25 May 2018…..

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……