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 BlogJune 18, 2021
On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for a broader range of medical devices to both...
See BlogSeptember 2, 2020
The delay gives medical device engineers the chance for a gap analysis and an optimized testing plan, says an expert chemist and toxicologist. The year 2020 was already going to be an “exciting” one for medical device companies, thanks to...
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June 13, 2020
The world of physics has a foundation built on beautiful universal constants, which work their way steadfastly into the equations governing electrodynamics, and then further extend themselves into our very hands in the design of smart interconnected electrical devices that...
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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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. |
