We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The medical device industry has been anticipating harmonziation between FDA's quality regulation requirements and the international consensus standard for medical device quality for years. Now, it ...
According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...
The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort ...
This webinar is intended to help you get familiar with FDA's Quality System Regulations (cGMP) for medical devices including in vitro diagnostic medical devices.
The Internet of Medical Things (IoMT) is a subset of the internet of things (IoT), which includes billions of devices connected to the internet, and often interconnected between them. The IoMT is a ...
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