North America Office
8757 West Cornell Avenue Suite 4
Lakewood, CO 80227 USA
+1 (720) 635-5563
Calle Arthur Ashe No. 40
San Juan Cosala
Jalisco C.P. 45820 Mexico
+1 (720) 635-5563
FDA 21 CFR 820 Documentation
FDA 21 CFR 820 Quality Management
Manufacturing medical devices?
Need to establish compliance with
Need to improve effectiveness of your
Folks on the floor do not always
Wish you could do things right the
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!