SaMD

By Dave Muoio March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry. “The exponential advancement of digital health technologies presents a...
By Heather Mack November 28, 2016
As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), Babyforyou.net.ua has learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device...
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