The draft is a near total overhaul of the document finalized by FDA in 2005, with only short sections on topics such as software verification and the history of software revisions surviving unchanged.

The computer vision leader offers controlled release cloud-based software to speed up innovation for life-enhancing drugs and medical devices PALO ALTO, Calif., May 2, 2023 /PRNewswire/ -- Landing AI, ...

Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes ...

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...

PROVIDENCE, Rhode Island, Oct. 22, 2020 /PRNewswire/ -- EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announced today that they have been awarded a two-year, $1.1 million contract from the Office ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Back to Healio The FDA has granted 510(k) clearance to a ...

Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "Validation of FDA-Regulated Medical Device & SaMD Products Using AI, ML & LLMs like ChatGPT (Oct 15, 2025)" training has been added to ...

DUBLIN--(BUSINESS WIRE)--The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering. This seminar will provide ...

(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities lie in leveraging AI, ML, and LLMs to enhance efficiency and effectiveness in FDA-regulated medical device and SaMD development. These ...