December 8, 2012
The Global Harmonization Task Force revision of its guidance on Essential Principles of Safety and Performance of Medical Devices is at the link provided. GHTF Essential Principles. It includes requirements for software that are similar to the European Union’s essential requirements relating to software.
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The GHTF is ending and will be replaced by a regulator-only organization, the International Medical Device Regulators Forum (IMDRF). This is the closing statement by the GHTF: GHTF-Closing-Statement.
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CSV Training Course

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

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