The new Medical Device Regulations (MDRs) become enforceable May 2022. After that, all new devices set for market in the European market will have to demonstrate compliance with ISO 10993,...
Many devices are a modified version of the “clean slate” device that was placed on the market decades ago and devices frequently change hands from one company to another and...
This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of...
This presentation was delivered at the CPhI tradeshow in Madrid, Spain on June 14, 2018. Passports, ID cards, fingerprints, metal detectors, iris recognition, camera’s… we are trying to reveal the...
The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate...
We use cookies to improve your site experience, assess usage of the site, and to support the marketing of our services. For information about how to set cookie preferences, please visit our Cookie Policy. If you agree to our use of cookies press “I Agree”, or continue to use our site, which will be considered consent. I AgreeCookie Policy
