该清单提供4小时的免费咨询，由对基本标准有第一手知识的专家提供，以回答有关标准和清单的问题，并在购买产品后60天内有效。这是ISO 14971:2019的清单。检查表的目的是明确定义基础标准要求的所有工件（政策、程序、计划、记录、文档或评审）。作者仔细审查了标准ISO 14971:2019，并根据该分类方案定义了所需的物证。SEPT的工程部门已经对完整的清单和基准标准进行了第二次审查，以确保文件的制作人不会遗漏一个合理的人可能会找到的实物证据。 该清单以PDF或word格式提供。后一种格式允许您根据您的商业案例或您的组织希望使用清单的媒体（如excel网页格式或任何其他最终产品类型）定制文档，以尽可能高效地符合标准。

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.