International: New ISO 13485

The international quality management system standard for medical devices – ISO 13485 – has been finally revised. With the official publishing date of March 1, 2016, companies have got time until March 1, 2019 to comply with its requirements. The key changes to the ISO 13485 include, among other, an enhanced focus on how device companies should manage risk-based decisions throughout the quality management system and additional requirements and clarity with regard to validation, verification and design activities.
The ISO 13485 is one of the most widely used standards in medical devices manufacturing in the world.

For more information please go to: new ISO 13485.