FDA Digital Health Innovation Action Plan

Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program.

Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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