The dawn of a new age in medical device risk assessments
After a development process that stretches back to the beginning of 2018, ISO has published the updated version of the International Standard ISO 10993-17. It has been a mammoth effort, involving over 100 scientists from 20 different countries (including bibra Senior Toxicologist, Chris Waine), and one that the toxicological and medical device worlds have been waiting for with bated breath.
Medical device submissions – protecting supplier confidentiality
We recently described – using a fruit label as an example – how an independent consultancy such as bibra could act as a third-party broker, providing a manufacturer with a safety evaluation of a multicomponent product while also protecting suppliers’ confidentiality over chemical composition. Here, we describe another example, in this case relating to a medical device submission to a Regulator or Notified Body.
Medical devices and CE certification
A medical device placed on the EU market must have a CE (“Conformité Européenne”) certification and comply with the EU Medical Devices Regulation (MDR; Regulation (EU) 2017/745)  or the EU In Vitro Diagnostic Medical Devices Regulation (IVDR; Regulation (EU) 2017/746) . Read our overview on the process, plus find out how we can help.
Biocompatibility Testing for Medical Devices: everything you need to know
Medical devices play a critical role in improving and maintaining human health. So why is biocompatibility important?