May 26, 2021
It is D-day, or the Day of Application (DoA) for the Medical Device Regulation (MDR) EU 2017/745. Years of hard work have preceded this date to prepare for this new regulation. The key message of the MDR is to minimize...
See BlogMay 7, 2021
Every medical device on the market must be evaluated for its potential to cause irritation, from a knee brace to an artificial cardiac pacemaker, regardless of whether it has a short-term or long-term exposure to the user/patient. This is a...
See BlogFebruary 18, 2021
The requirements for assessing irritation for medical devices has moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing as a recognized method. This is a critical turning point as...
See BlogSeptember 24, 2020
Irritation testing is identified as one of the most performed biocompatibility tests for medical devices. This is due to the requirement for evaluation which is laid out in ISO 10993-1:2018: Biological evaluation of medical devices –Part 1: Evaluation and testing...
See BlogApril 1, 2020
The 566-page Medical Device Regulation (MDR), which replaces the EU’s Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC), has caused much discussion, training, debate, and stress in the medical device industry since its publication in...
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