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For
FDA Software Standards
Off-the-Shelf
Software Use in Medical Devices |
Evidence
Product Checklist for the FDA Document
“Guidance for Industry, FDA Reviewers
and Compliance on Off-the-Shelf Software Use in Medical Devices” September
9, 1999, as amended by “Guidance
for Industry, FDA Reviewers and Compliance on Cybersecurity for Networked
Medical Devices Containing Off-the Shelf (OTS) Software" January 14,
2005
by Stan Magee (read
about the author)
E-Book
21 Pages
Published June 2005
Download (PDF) 44 KB
Item No.: RCG15SEPTRCG
List Price: US $ 149.00 |
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Description
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 ! |
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