BASE QUALITY MANAGEMENT SYSTEM
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.
DESIGN QUALITY MANAGEMENT SYSTEM
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.
DESIGN AND MANUFACTURING QMS
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.
"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