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Checklist for ISO 14971:2019, Medical Device Software - Software Life Cycle Processes
Pages: 143
Publication date: 0000-00-00
Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes
Pages: 105
Publication date: 2007-03-01
Checklist for the FDA Document Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices? As Amended by ?Guidance for Industry, FDA Reviewers and Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software
Pages: 21
Publication date: 2005-05-01
SEPT EVIDENCE PRODUCT CHECKLIST for ISO/IEC TR 90006:2013. Guidelines for the Application of ISO 9001:2008 to IT Service Management and its Integration with ISO/IEC 20000-1:2011
Pages: 150
Publication date: 2013-09-22
CHECKLIST-For Standard IEC 60601-1 Ed. 3.0 b: 2005 ***DOES NOT INCORPORATE 2012 AMENDMENT***, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Clause 14 Programmable Electrical Medical Systems (PEMS)
Pages: 44
EVIDENCE PRODUCT CHECKLIST for ANSI/AAMI/ISO Standard 13485:2003 Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes
Pages: 71
Publication date: 2004-07-01
Evidence Product Checklist for the FDA Document "FDA 21 CFR Part 11: Electronic Records; Electronic Signatures; Final Rule"
Pages:
Publication date: 2001-10-01
SEPT IEC 60601-1-4 *(Edition 1.1 2000-04)* Evidence Checklist - Medical Electrical Equipment - Part 1: General Requirements for Safety
Pages: 80
Publication date: 2001-08-01