QMED is a part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Sign In

Biological Evaluation of Medical Devices as an Essential Part of Risk Management Process: Updates and Challenges of ISO 10993-1:2018

Eurofins Medical Device Testing

Biological Evaluation of Medical Devices as an Essential Part of Risk Management Process: Updates and Challenges of ISO 10993-1:2018

Whitepaper – Eurofins Medical Device Testing

In August 2018, a new version of ISO 10993-1 was published, which highlighted the importance of gaining deeper knowledge of the device. In the new version of the standard, not all biological effects should be assessed by biological testing. Some tests can now be waived if there is a sound rationale to support the decision. Read more in our whitepaper.