Guidance for compliance with Off-the-Shelf Software Use in Medical Devices, Cybersecurity
Download, PDF format, 44 KB, 21 pages, (also available in MS WORD format)
Item No.: RCG011ASEP, published June 2005
This new edition of the checklist Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices has been updated to reflect the suggested compliance with the document ”Compliance on Cybersecurity 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. The purchase of the checklist includes four hours of free consultation - during 60 days after date of purchase - concerning the standard or the checklist. Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements. A quality product at a reasonable price !