Our Approach

The RQM+ Approach

We are changing the way medical device and diagnostics manufacturers use consulting. Our highly collaborative process begins with understanding and defining your business objectives, scope, and the resulting deliverables. Our focus is on delivering a risk-balanced, tailored solution to support your business success.

Why Leading Global Manufacturers Rely on RQM+

Seasoned Business

With more than 35 years in operation as a consulting business, RQM+ is a dependable, trusted expert with strong industry connections.

Scalable Team

Our team of more than 450 people come from all levels of experience, allowing us to deliver right-sized solutions based on your needs.

Extensive Expertise

With more than 100 resources who each have at least 20 years of industry experience, you can be confident that your project is in good hands.

Former Regulators

We recruit former regulators from FDA and competent authorities, as well as former notified body leaders to bring exclusive insights into your regulatory and quality challenges.

Leadership Skills

The RQM+ team is steeped with management and leadership experience, allowing us to operate as an extension of your business.

Learning Ecosystem

Our collective knowledge evolves as we learn from each other and integrate these lessons into our processes and systems to the benefit of all our clients.

The Ways RQM+ Works With You

Whether you need an individual resource managed by our team or complete ownership of your regulatory and quality deliverables, or anywhere in between, we have the right-sized solution focused only on your success. Explore the levels of support we provide.

RQM+ Skilled Resources

We build and manage a team based upon industry expertise and capabilities to fit your needs. Whether you're adding capacity to your internal regulatory and quality teams or utilizing our industry experts to solve your biggest challenges, we've got you covered.

RQM+ Project Management

When in addition to technical resources you need project management support, we ensure that deliverables of the collective team are on time and on budget. Our project managers are seasoned medical device professionals with a deep understanding of regulatory and quality initiatives.

RQM+ Consulting Leadership

This is our sweet spot and where most clients see the greatest success. We’ll work together to define the project scope, objectives, deliverables, and governance structure and take the lead in developing the strategy and executing all the necessary tasks. We'll provide technical leadership, project management, and a team of experts for a seamless execution.

RQM+ Managed Outsourcing

If you are looking for a partner you can trust to handle every aspect of your RA and QA support needs, we’ll assemble and manage the best team to do it. Think of us as an extension of your business and a trusted partner that is invested in your strategic plan.

MDR Filtering Tool

The RQM+ Approach