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.