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