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 BlogJanuary 5, 2021
In October 2020 FDA released a new draft biocompatibility guidance document which focuses on the biological evaluation of devices in contact with intact skin. As a draft document, it is therefore open for comments and possible changes. Release of this...
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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August 21, 2019
The new European Union (EU) Medical Device Regulation (MDR) will impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from the previous directives, especially in...
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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. |
