Quality Manual for Medical Devices



If you are searching for a quality manual for medical devices, look no further.  

Implementation of our documented, quality manual for medical devices will enable you to meet the FDA's CFR 21 Part 820: Quality System Regulation at a reasonable price. You will receive sensible/flexible procedures which, when implemented, will reduce your paperwork to a minimum and will enable you to significantly improve the quality of your products/services.     

Our quality manual for medical devices is designed for small organizations and includes 27 procedures and 34 forms/checklists, which you customize specifically for your needs.  

Best of all, due to its unique design, your manual can be uploaded to your company web site and viewed through a web browser or any Smartphone with an internet account.  You can collaborate with your customers, suppliers, and team members anywhere in the world.  

Testimonial:  "The Quality Manual for Medical Devices is exactly what we needed and then some.  It is very well written and virtually bug-free so we have been able to make immediate use of the material.  Thank you very much."

Peter Brownhill, President & CEO, Nexma Technologies

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If you are seeking an ISO 13485 quality manual for medical devices, click here: ISO 13485 Quality Manual for Medical Devices