ISO 13485 does not spell out the specific measures for device manufacturers to take. However, the certification gets people in the mindset that quality happens at every stage of manufacturing and that ...

Stratasys Direct facility in Tuscon, Arizona, achieves ISO 13485 certification, and is now formally recognized for safety and reliability.

ROSEMONT, IL, USA, 01/06/2020 – Proteintech Group, Inc, the benchmark in antibodies and proteins, announces completion of its ISO 13485 certification for medical devices. With this certification, ...

today announced that it has received ISO 13485:2016 certification from the British Standards Institute (BSI). “This ISO certification is a major step in our journey toward delivering high ...

today announced that it has received ISO 13485:2016 certification from the British Standards Institute (BSI). "This ISO certification is a major step in our journey toward delivering high-quality ...