Products For Medical Devices, Checklists, Guides for FDA Related Software

Medical Device Software Checklist Kit (DOCX)  For ISO 13485, ANSI/UL 1998, IEC 62304, ISO 9001, ISO/IEC 90003, FDA Pre-market Submissions, Software Validation, Off-the-Shelf Software, Cybersecurity Download (zip) 5,363 KB, .docx format Item No.: RCG056AWSEP   ...more information        Medical Device Software Checklist Kit (PDF)  For ISO 13485, ANSI/UL 1998, IEC 62304, ISO 9001, ISO/IEC 90003, FDA Pre-market Submissions, Software Validation, Off-the-Shelf Software, Cybersecurity Download (zip) 738 KB, .pdf format Item No.: RCG056ASEP   ...more information        ANSI/UL 1998:2004 Checklist (MS WORD)  Checklist for the application of the standard ANSI/UL 1998:2004 for Software in Programmable Components Download, (MS WORD format), 558 KB, 86 pages, (also available in PDF format) Item No.: RCG019AWSEP, published October 2004   ...more information        IEC 62304:2006 Medical Device Software Life Cycle Processes -MSW  Evidence Product Checklist for IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes Download, MS WORD format, 1,522 KB, 105 pages (also available in PDF format), Item No.: RCG014AWSEP, Published March 2007   ...more information        FDA 21 CFR Requirements Evidence Checklist (MS WORD)  For the standard FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, Final Rule Download (MSWORD format), 540 KB, 31 Pages, (also available in MS WORD format) Item No.: RCG013ARCG, published October 2001   ...more information        Pre-market Submissions of Software in Medical Devices (MS WORD)  Checklist for FDA Guidance for the content of pre-market submissions for software contained in medical devices Download, MS-WORD format, 782 KB, 83 Pages, (also available in PDF format) Item No.: RCG012BWSEP, published March 2005   ...more information        FDA Off-the-Shelf Software in Medical Devices (MS WORD)  Guidance for compliance with Off-the-Shelf Software Use in Medical Devices, Cybersecurity Download, MS Word format, 556 KB, 21 pages, (also available in PDF format) Item No.: RCG011AWSEP, published June 2005   ...more information      Result Pages:  1