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FDA 21 CFR 820 Documentation

Quality manuals
Documentation sets

FDA 21 CFR 820 Documentation - Quality Works offers documentation sets for FDA 21 CFR 820

FDA 21 CFR 820 Quality Management System

  • Manufacturing medical devices?

  • Need to establish compliance with regulatory requirements?

  • Need to improve effectiveness of your QMS?

  • Folks on the floor do not always follow procedures?

  • Wish you could do things right the first time?

We can help! If your company manufactures or sells medical devices in the United States, the company is required to have a quality management system compliant with FDA 21 CFR 820 Quality System Requirements (QSR).  Quality Works team has developed and offers documentation templates for FDA 21 CFR 820 Quality Management System (QMS).  Use of templates is a widely used approach to establishing and documenting a quality management system. Quality Works assisted dozens of companies around the World in establishing and implementing effective QMS. Our documentation sets will save you time and money for documenting your FDA 21 CFR 820 compliant quality management system.


Feel free to compare our documentation with others: you will find that our products are the most effective, simple and yet addressing all the requirements of FDA 21 CFR 820 standard.  Quality Works team designed our documentation to truly improve effectiveness of your documentation system and reduce paperwork.  Our documentation is user-friendly, easy to understand and makes good business sense.  Check our Download page to see samples of our documents. While our FDA 21 CFR 820 quality management system documents are easy to customize and implement, our team is always here to assist you in your project.  Check our Consulting, Training and Auditing pages to learn how our experts can give you a jump-start in developing and implementing your FDA 21 CFR 820 quality management system. Visit our Product page to order your medical device QMS documents.

Call us today to discuss your specific ISO management system needs!

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