LCPfirmware LLC

Specializing in documentation to support medical device firmware development which is cost effective and compliant with:

  • IEC 60601-1 Medical electrical equipment - Part 1: General...performance, Paragraph 14 - Programmable Electrical Medical Systems (PEMS)

  • IEC 62304 Medical device software – Software life cycle processes Edition 1.1 2015-06

  • FDA 337 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on: May 11, 2005

  • FDA 585 Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices issued on September 9, 1999


Ben Landry
Cell: 770-231-5297
blandry@LCPfirmware.com

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