ISO 13485 Quality Management Systems Aligned With Your Specific Needs.

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BASE PLUS QUALITY MANAGEMENT SYSTEM (CORE QMS PROCEDURES)

The Medical Device Quality Management System | BASE PLUS is a foundational product that contains core procedures for companies engaged in the design and manufacture of medical devices. Additional procedures can be easily added as needed. A perfect starter package for those who desire the minimum required content to obtain ISO 13485:2016 certification and FDA QSR compliance. ​
  • Quality Management System Manual
  • 38 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​

QUALITY MANAGEMENT SYSTEM FOR DESIGNERS ( SPECIFICATION DEVELOPERS)
The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. ​
  • Quality Management System Manual
  • 46 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​

QUALITY MANAGEMENT SYSTEMS FOR COMPANIES ENGAGED IN BOTH DESIGN AND MANUFACTURING 
The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices, including software, seeking ISO 13485:2016 certification and FDA QSR compliance.​
  • Quality Management System Manual
  • 72 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download 
DO THE MATH
When you consider the hours required to develop a system internally or the cost associated with hiring an outside consultant to develop a quality management system for you, we trust that you will see the value of our product offerings.

A.P. Lyon has served medical device companies in 43 countries, including:

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Testimonials

"We used the MFG PLUS QMS product designed for medical devices. We aligned the system to our organization and devices. A P Lyon's procedures were very handy and easy to implement in a couple of months"​ Bal G.
"These products are the real deal. We were up against a deadline for ISO 13485 certification and needed a solution. The A.P. Lyon products were just what we needed. The content is simple to understand but has a depth of content at the same time. The perfect balance and a solid product. Thanks! " Curtis Smith
"The Manufacturing Plus product was a tremendous help for us to be ISO 13485 certified as we couldn't spare the resources to start from scratch. Highly recommend this product!" Deb Hartman
​ISO 13485 Quality Management Systems Aligned With Your Specific Needs.
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