ISO 13485 Contamination Control Procedure & Product Cleanliness
Waqas Imam
Updated: October 24, 2023. By maintaining the ISO 13485 contamination control procedure and strict control measures, manufacturers can minimize the...
Updated: October 24, 2023. By maintaining the ISO 13485 contamination control procedure and strict control measures, manufacturers can minimize the potential for contamination and uphold the quality and reliability of their medical devices. In this...
How to use ISO 13485:2016 to manage implantable medical devices
A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended...
A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended to stay in a human body for an extended period of time. Devices that interact...
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...
Infographic: What’s new in the 2016 revision of ISO 13485
Strahinja Stojanovic
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...
