The checklist comes with 4 hours of free consultation, from experts that have firsthand knowledge of the underlying standard, to answer questions on the standards and checklists and is valid for 60 days after purchase of the product. This is a checklist for ISO 14971:2019. The purpose of the checklist is to define clearly all the artifacts (policy, procedure, plan, records, document, or reviews) that the underlying standard calls out. The author has carefully reviewed the Standard ISO 14971:2019 and defined the physical evidence required based upon this classification scheme. SEPT's engineering department has conducted a second review of the complete list and baseline standard to ensure that the documents? producers did not leave out a physical piece of evidence that a reasonable person would expect to find. The checklist is available in PDF or word format. The latter format allows you to tailor the document to your business case or the media that your organization wants to use the checklist in such as excel web page format or any other end product type in order to meet compliance with the standard in the most efficient way possible.