Quality System Framework for the Global Compliance Spectrum

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Compliant Quality Management Systems for Startups and Established Medical Device Companies

The implementation and maintenance of an efficient and effective Quality Management System is the foundation of regulatory compliance around the world.

It is critical that an organization be able to demonstrate compliance throughout the development lifecycle, beginning with conceptualization through commercialization. While an entire QMS is not needed during the pre-production phase, an initial implementation of a partial quality system, including controls for design and development, and documentation and records systems ensures regulatory compliance with technical and design documentation requirements, and simplifies the implementation of the full QMS.

A staged implementation of the QMS allows for planning and improving the QMS during the product development and ensures compliance readiness at the time of registrations and listing.

Maintenance of the post-production QMS requires diligent follow-up and tracking of regulatory compliance, followed by updates of documentation, verification/validation, training and sometimes notifications of significant changes to regulatory authorities. Managing all of these activities while maintaining up-to-date, compliant procedures can be a daunting process.

QMS Implementation, Maintenance, and Upgrades

Whether you’re marketing in a single market or globally, we have the resources and expertise to help you establish and maintain an efficient and effective quality management system that is continuously compliant with all market requirements. Our expert QMS consultants have specialized in QMS implementation and compliance for at least 25 years and can provide assistance in any market globally.

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QA/RA Consulting Group has extensive experience establishing quality management systems that are compliant with ISO 13485, US FDA 21CFR 820 Quality System Regulation, EU Medical Device Regulation (MDR) / In-Vitro Diagnostic Device Regulation (IVDR), MDSAP, and other global quality system requirements. We can also perform internal quality system and readiness audits.

A pre-production QMS is typically established during the feasibility stage of the design project, and includes document and records controls, design and development, human factors engineering, risk management, software development, supplier selection and evaluation, and control of inspection and test equipment.

A full QMS is established by the time the medical device is registered with the applicable regulatory authorities and is maintained through continuous monitoring, internal quality audits and management review.

Our QMS implementations and process re-engineering efforts have focused on the following:

  • Global Quality System Development

  • ISO 13485 / ISO 9001 / FDA QSR 

  • Cleanroom / Controlled Environment/Controls

  • Best Practices / Process Re-engineering

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