April 7, 2022
This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...
See BlogMay 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...
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Regulatory Compliance Associates is now part of Nelson Labs! RCA's quality, regulatory, and technical experts know how to navigate complex challenges and help life science companies safely maximize their market potential. |
