ISO 13485:2016 – new medical devices standard

ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.

With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and even in vitro diagnostic reagents.

Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.

There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.

For more details, see: ISO.



 Posted by Dr. Tim Sandle