Stay compliant with ISO 13485:2016! This is a Checklist for ANSI/AAMI/ISO Standard 13485:2016 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. 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!