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    • Self Extracting File Format
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New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!

SEPT has produced a checklist for the FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices May 11, 2005 document This is a "must have" for all quality managers and engineers involved in this FDA document. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This standard calls out or suggests over 120+ items of physical evidence. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any organization to meet the requirements of this important standard. Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or checklist for 60 days after purchase.

New! Interested in an unlimited 5-year corporate license for this product? Contact Software Engineering Process Technology (SEPT) for more information! Tel. 425-391-2344, Fax 425-557-9419.

 

Document History

  1. Evidence Product Checklist for FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, May 11, 2005

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    Evidence Product Checklist for FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, May 11, 2005

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  2. FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - Evidence Product Checklist


    FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - Evidence Product Checklist

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