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For
FDA Software Standard
Pre-market Submissions
for Software Contained in Medical Devices
Checklist |
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Evidence
Product Checklist for the FDA Document
“Guidance for the Content of Pre-market
Submissions for Software Contained in Medical Devices”
by Stan Magee
E-Book
48 Pages
Published March
2000
Download (PDF) 91 KB
Item No.: RCG16SEPTISO
List Price: US $ 149.00 |
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Description
Checklist for the software engineering
medical device guidance document: FDA Guidance for the Content of Pre-market
Submissions for Software Contained in Medical Devices. 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 FDA document. The purchase of the checklist includes four hours
of free consultation during 60 days after date of purchase, concerning
questions about the FDA document and the checklist. Use of the Checklist
will save time and money, and may aid in meeting certain governmental requirements.
A quality software engineering aid at a reasonable price ! |
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