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ISO 13485:2016 Requirements Checklist (PDF)

Sample Page

MS Word docx - $299.00

Checklist for ISO 13485:2016, Medical Device Software - Software Life Cycle Processes
Download (PDF format), 738 KB, 176 pages, (also available in MSWORD docx format)
Item No.: RCG055SEP, published March 2016


The Checklist for the standard "ISO 13485:2016 Medical Devices - Quality Management Systems" provides information and assistance for the compliance with the requirements of the standard and compliance with applicable regulatory requirements related to medical devices. This includes design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product including quality management system-related services to such organizations.
The purchase of this checklist includes four hours of free consultation during 60 days after date of purchase, providing answers to questions about the standard and checklist. Using the checklist saves time and money, and will aid in meeting certain regulatory requirements! The Checklist is a quality product at a reasonable price!

> For more detailed information please see the Sample Pages (use link above)


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