Products Software Engineering

FDA requirements, Kit of Checklists for Medical Device Firms  For ANSI/AAMI/ISO 13485, ANSI/UL 1998, IEC 60601-1-4, IEC 62304, ISO 9001, ISO/IEC 90003, FDA Pre-market Submissions, Software Validation, Off-the-Shelf Software, Cybersecurity Download (zip) 1,529 KB, 9 Files (PDF) Item No.: RCG027BSEP, published January 2010   ...more information        ISO/IEC 15288:2008 Requirements Checklist  Checklist for ISO/IEC 15288:2008 System and Software Engineering - System Life Cycle Processes, 2nd edition Download (PDF) 386 KB, 202 pages Item No.: RCG018ASEP, published December 2008   ...more information        FDA 21 CFR Requirements Evidence Checklist  for the standard FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, Final Rule Download (PDF) 55 KB, 30 Pages Item No.: RCG013ARCG, published October 2001   ...more information        ISO/IEC 12207:2008 Requirements Checklist  For the implementation and compliance with the standard ISO/IEC 12207:2008 - Software Life Cycle Processes. Download, PDF. 388 KB, 222 pages Item No.: RCG008ARCG, published May 2009   ...more information        ISO/IEC 27002:2005 Checklist  For ISO/IEC 27002:2005 Information Technology, Security Techniques, Information Security Management Download (PDF) 328KB, 185 pages Item No.: RCG031ASEP, published January 2008   ...more information        ISO/IEC 20000-1:2005 Checklist  Evidence Product Checklist for Information Technology - Service Management - Part1: Specification Download (pdf) 276 KB, 56 pages Item No.: RCG032ASEP, published October 2008   ...more information        ISO/IEC 90003:2004 Checklist  Checklist for the application of the guidelines of ISO 9001:2000 to computer software Download (PDF) 223 KB, 114 pages Item No.: RCG009ASEP, published April 2004   ...more information        ANSI/AAMI/ISO 13485:2003 Requirements Checklist  For compliance with ANSI/AAMI/ISO 13485:2003 Medical Dvices - Requirements for regulatory purposes Download (PDF) 160 KB, 71 pages Item No.: RCG022ASEP, published June 2004   ...more information        ANSI/UL 1998:2004 Checklist  Checklist for the application of the standard ANSI/UL 1998:2004 for Software in Programmable Components Download (PDF) 145 KB, 86 pages Item No.: RCG019ASEP, published October 2004   ...more information        IEC 60601-1-4 Checklist  For thr standard IEC 60601-1-4 Medical Electrical Equipment, General Requirements for Safety, Programmable Electrical Medical Systems Download (PDF) 135 KB, 80 pages Item No.: RCG007ASEP, published August 2001   ...more information        IEC 62304:2006 Checklist  Evidence Product Checklist for IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes Download (PDF) 250 KB, 105 pages Item No.: RCG014ASEP, Published March 2007   ...more information        ISO/IEC 90003:2004 Supplier Assessment  For supplier assessment in compliance with the guidelines of ISO 9001 to computer software Dowmload (PDF) 124KB, 50 pages Item No.: RCG030ASEP, published January 2006   ...more information        ISO 9001:2008 Evidence Product Checklist  Evidence Product Checklist for the standard ISO 9001:2008 Quality Management – Requirements Download (PDF) 138 KB, 51 pages Item No.: RCG017ASEP, published January 2009   ...more information        Template-Kit for Software Engineering Management  Templates for software configuration, documentation, maintenance. Satisfies ISO/IEC 12207, ISO/IEC 15288, IEC 62304, IEEE 14764 Download (ZIP), 4 PDF files, 2,399 KB Item No.: RCG023CSEP, published December 2009   ...more information        FDA Guide, Pre-market Submissions, Software in Medical Devices  Checklist for FDA Guidance for the content of pre-market submissions for software contained in medical devices Download (PDF) 619 KB, 83 Pages Item No.: RCG012BSEP, published March 2005   ...more information        FDA Software Validation Checklist  For the FDA document General Principles of Software Validation - Final Guidance for Industry and FDA Staff Download (PDF) 178 KB, 118 pages Item No.: RCG010ASEP, published March 2002   ...more information        FDA Off-the-Shelf Software in Medical Devices, Checklist  Guidance for compliance with Off-the-Shelf Software Use in Medical Devices, Cybersecurity Download (PDF) 44 KB, 21 pages Item No.: RCG011ASEP, published June 2005   ...more information        Templates for Software Configuration Management  Set of templates for Software Configuration Management Documents for IEC 62304, ISO/IEC 15288, ISO/IEC 12207 Download (PDF) 260 KB , 106 pages Item No.: RCG024ASEP, Published August 2009   ...more information        Template for a Software Maintenance Plan  Templare for implementation of operation and maintenance processes according to ISO/IEC 12207 and ISO/IEC 14764 Download (PDF) 277KB, 38 pages Item No.: RCG025ASEP, published June 2008   ...more information        Template for a System Documentation Mgmt. Plan  The template satisfies ISO/IEC 15288:2008, System Life Cycle Processes, Section 6.3.6 Download (PDF) 1,116 KB, 95 pages Item No.: RCG026BSEP, published December 2009   ...more information      Result Pages:  1  2  [Next >>]