ISO 13485:2016 nonconforming product – How to approach the post-delivery actions
Waqas Imam
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical...
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a...
How to comply with ISO 13485:2016 requirements for handling complaints
Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and...
Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and...
Mandatory documents required by ISO 13485
Strahinja Stojanovic
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016...
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016 documentation requirements are based on the requirements of the previous version of ISO 9001, with...
Infographic: What’s new in the 2016 revision of ISO 13485
To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs....
To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs. ISO 13485. The new 2016 revision of ISO 13485, the leading international standard for...
