This item is not available for sale.

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

View Sample Pages.

Checklist for the standard: ANSI/AAMI Standard SW68. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. It identifies over 350 pieces of physical evidence. This checklist clarifies what is required for compliance to this standard by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard.

For medical device firms, use of the Checklist will save time and money, and may aid in meeting certain governmental requirements.

Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.

The Checklist is a quality product at a reasonable price!

 

Document History

  1. SEPT IEC 62304 Checklist


    IEC 62304:2015, Medical Device Software - Software Life Cycle Processes

    • Most Recent
  2. SEPT IEC 62304 Checklist


    Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes

    • Historical Version
  3. EVIDENCE PRODUCT CHECKLIST For ANSI/AAMI Standard SW68

    👀currently
    viewing


    EVIDENCE PRODUCT CHECKLIST For ANSI/AAMI Standard SW68

    • Historical Version