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Medical Device Quality System Templates

Quality Systems for Medical Device Startups and Small Businesses
  • FDA QSR Compliant
  • EU and Canadian MDR Compliant
  • ISO 13485:2016
  • ISO 14971 - Risk Management
  • Ready to Implement
  • Provided in Editable Format​​
100% Satisfaction Guarantee
If you are not satisfied for any reason, Med Dev QMS will refund your entire purchase price!
Med Dev QMS Templates are proven procedures that are efficient and easy to understand. These procedures were written by quality professionals from startup and small companies and have been successfully utilized to launch medical devices in the US, Canada, the European Union, and more. This robust system is capable of supporting everything from new product development to complete outsourcing of manufacturing and distribution.  We have had clients with only ten employees utilize this system to become Level 1 Critical Suppliers to some of the largest medical device companies in the world.

Being written by quality professionals from small businesses is incredibly important, because most other companies are offering templates that were created by auditors or professionals from very large organizations. They offer seventy five plus procedures full of specific requirements and complexity that would take a small army to maintain. Med Dev QMS Templates provide a simple, straight-forward QMS solution that can be modified to fit your organization and grow with the business while being managed by a single quality professional.

Let Med Dev QMS provide a solid foundation for your quality systems and free up resources to focus on your products and getting to market faster.  Med Dev QMS can provide complimentary quality system strategy and implementation consultations with the purchase of our templates to ensure your startup or small business success.

The med dev qms Quality system package includes:

Quality Manual, Procedures, & Forms
Click Here for Example CAPA Process
File Size: 353 kb
File Type: pdf
Download File

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Easy to Navigate File Structure with
​Extra Templates
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Purchase Package
The Med Dev QMS Quality System Templates are a registered copyright of Med Dev QMS, LLC and any attempt to duplicate or redistribute for profit is explicitly prohibited.
ISO 13485:2016, FDA QSR Compliant Quality Management System Templates
Med Dev QMS, LLC
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