The "Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course" training has been added to ResearchAndMarkets.com's offering. This course will provide a clear ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment ...

Regulatory Outlook Medical Device Clinical Trials in Japan In an effort to globally harmonize medical device clinical trials, Japan has implemented new regulations on how to develop and conduct them.