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Regulatory Standards › International Medical Device Regulators Forum (IMDRF)

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Stinson LLP

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

Stinson LLP on

On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more

Hogan Lovells

FDA’s Software Pre-Cert Program: More Details Revealed

Hogan Lovells on

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

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