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FDA OTS SW STD CK/L

2012 Edition, January 4, 2012

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SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR THE FDA DOCUMENT: “"GUIDANCE FOR INDUSTRY FDA REVIEWERS AND COMPLIANCE ON OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES”"



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Document Number - SEPT FDA INDUSTRY GUIDANCE Software Engineering Process Technology - Evidence Product 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 Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software" The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005. This checklist reflects these new requirements. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The Checklist clarifies what is required for compliance through a product evidence list that will assist any software organization in meeting the requirements of this guideline.