RAQA Docs

Your Source for Regulatory and Quality Templates

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About RAQA Docs

QMS Documentation

Our QMS documents are created based on the ISO 9001:2015 and ISO 13485:2016 standards. Simply adjust our professional templates to reflect the unique aspects of your business.

Medical Device Industry Support
Written by experienced Regulatory and Quality professionals, our templates for the medical device industry address compliance needs for regulations of the MDSAP regions (U.S., Canada, Australia, Japan, Brazil), the EU MDR 2017/745 and UK medical device regulations.

Commitment to Quality
All documents are written by seasoned professionals. The documents are designed for easy navigation, with a simple, polished style to delight customers and auditors alike. We continuously monitor the current state of the applicable standards and medical device regulations, to ensure that the materials you receive reflect the current state of the quality and regulatory landscape.

Get a head start with our templates!

Whether you are just getting started on implementing a Quality Management System or looking to improve your current system, RAQA Docs has the resources you need to make your work easier and faster! 

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Quality Management System procedures

ISO 9001, ISO 13485

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Regulatory and Quality templates

to support compliance to medical device regulations

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Training materials

to support awareness of regulatory and quality requirements

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Checklists and forms

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And more!

to help you kickstart your compliance efforts!

What WE OFFER

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