eg technology completes ISO 13485:2016 recertification

16th October 2018

We have now completed our transition to ISO 13485:2016 and gained recertification. The EU Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) requires manufacturers to be complaint by May 26 2020. Designing a medical device or IVD under a ISO1385:2016 quality management system supports the legal manufacturers overall compliance to this regulation for the device.