This item is not available for sale.

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

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

SEPT is pleased to announce another new checklist.

This is a Checklist for ANSI/AAMI/ISO Standard 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes ISO 13485. This standard is a requirement for all medical devise producers. This standard goes much further than ISO 9001 in requirements for documentation; and represents a major change in concept, being a "stand-alone" quality system standard for medical devices. 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.

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. Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes


    Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes

    • Most Recent
  2. SEPT ISO 13485 Checklist

    👀currently
    viewing


    EVIDENCE PRODUCT CHECKLIST for ANSI/AAMI/ISO Standard 13485:2003 Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes

    • Historical Version