Checklist for FDA Guidance for the content of pre-market submissions for software contained in medical devices
Download, PDF format, 619 KB, 83 Pages, (also available in MS WORD format)
Item No.: RCG012BSEP, published March 2005
This is a Checklist for the application and compliance with the document FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices’.
This is a “must have” for all quality managers and engineers involved in applications concerning this FDA document.
The checklist uses an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. Over 120+ items of physical evidence are called out or suggested.
The checklist clarifies what is required for compliance with the FDA Guidelines by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of the 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 helps in meeting certain governmental requirements. A quality software engineering aid at a reasonable price !