Medical consumables company Poly Medicure Ltd on Tuesday (March 11) announced that it has received Medical Device Regulation ...
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Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Regulatory Milestone Expands Access to Advanced Transplant Technologies Across Europe Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced ...
A comprehensive and forward-looking regulatory framework for emerging technologies can address integration challenges, ...
Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize ...
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
The UK Government has accepted most of the recommendations of the Regulatory Horizons Council (RHC) on the regulation of AI in medical devices.
The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is ...
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