Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices
International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The
Importance of Data Integrity and Document Management
In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibili
Tips for transitioning to ISO 13485:2016
As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the transition, it is important
