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 BlogFebruary 14, 2022
Cytotoxicity endpoint is marked for all medical devices that contact the patient/user, regardless of type or duration of contact. A cytotoxicity test is an in vitro cell culture assay where the medical-device extract is placed in contact with mammalian fibroblast...
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 BlogSeptember 1, 2020
It is important to have an appropriate testing protocol in place for this relatively new medical technology. Medical devices have become increasingly complex over time and incorporation of “smart” features has become commonplace. These improvements may increase effectiveness of implantation,...
See BlogAugust 1, 2019
Our technical consulting group at Nelson Laboratories acts as a bridge between medical device companies and regulatory bodies, putting us in a good position to understand both sides and what they need from each other. This also creates an opportunity...
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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. |
