Transformative Compliance Solutions That Deliver Business Value
Evolving regulations are forcing manufacturers to quickly rethink their current compliance practices, internal methodologies, and ongoing level of compliance investment. RQM+ provides an all-encompassing compliance solution, including leadership, strategic planning, program management, and a tactical execution team to address all challenges.

Our scalable team helps you tackle any compliance challenge.

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Our transformative compliance solutions were developed specifically to navigate the intricacies of today’s regulatory environment, including compliance strategies from risk-based necessity to value-driven solutions. We provide leadership, strategy development, project management, and a scalable execution team to address any compliance issues that arise.

When faced with deficiencies from an FDA inspection or notified body audit, many manufacturers do not have the bandwidth or experience to respond confidently, let alone make a positive transformation at the same time. Our seasoned team will create a response strategy that builds value and improves corporate compliance.

Our industry expertise allows us to create right-sized solutions, with streamlined CAPA processes that identify compliance issues, investigate, and provide resolutions, so you can avoid 483s and warning letters. Taking appropriate Corrective and Preventive Actions that are focused on the problems and provide direct, sustainable solutions are key to successfully addressing regulatory compliance concerns and building credibility with regulatory agencies.

Unfortunately, recalls are a fact of life for medical device and IVD manufacturers. RQM+ optimizes your recall process to ensure integration with post-market surveillance, applicability to all recall classifications, and a streamlined response plan. RQM+ supports you with a situation analysis, health hazard evaluation, risk-management file review and update, recall strategy, and communication plan to your customers and the agency. From simple issues to emergency responses, we are ready to help you.

Responding to 483s, warning letters, consent decrees, and notified body (NB) non-conformity reports can be daunting. With RQM+, you receive value-added, strategic guidance and solutions that reduce risk and the potential for business interruptions. RQM+’s goal is to help our clients achieve a long-term state of ‘compliance health.'

Subject Matter Expert Support

Subject Matter Expert Support

Add SME scalable capacity to your internal regulatory compliance team for specific projects or tasks, on a short- or long-term basis.

Technical Management

Technical Management

When you need deeper involvement from a consultant but want control of the overall project, our technical leaders can help you refine processes and handle documentation.

Complete Remediation Solution

Complete Remediation Solution

For maximum value from our seasoned team, let RQM+ handle every aspect of regulatory compliance, including leadership, strategic planning, project management, and executing all necessary tasks with a scalable team of experts.

Regulatory compliance is reactive by nature, but our proactive approach adds value and creates opportunity for improvement.

Learn more about the RQM+ approach

We’re far more than remediation consultants. RQM+ is your emergency response team when FDA or your NB arrive unannounced. We're also your strategic partner, providing business value in difficult times.

483s and Warning Letters

You have to act fast when you get any type of notification from a regulatory agency. With RQM+ on your team, you have access to the expert resources you need to respond and remediate.

Learn more about FDA 483s and Warning Letters

Non-Conformance Reports

With the rollout of the MDR and IVDR, notified bodies have significantly increased scrutiny during conformity assessments. The result is more manufacturers having to respond to non-conformance reports. With former notified body leadership and seasoned industry experts on staff, we know what to look for. We can help you address non-conformities when they arise, and even avoid them in the first place.

Proactive Solutions

The more prepared you are for an audit, the less work you must do in the long run. The RQM+ team has seen it all, from every angle, so we know the best practices for maintaining compliance and avoiding audit findings and recalls.

When your internal medical device regulatory compliance team is overwhelmed, RQM+ immediately refines processes and fills skills gaps with our expert resources. We also collaborate with you to build in-house skills and capabilities to deliver transformative solutions.

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Strategic Direction
We think beyond compliance to add value and transform core business culture.

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Integrated Approach
We understand how all aspects of medical device and IVD manufacturing affect compliance.

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Industry Leadership
Deep industry connections keep us ahead of the constantly changing regulatory landscape.

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Regulatory Affairs by Region

Regulatory Compliance in the US

In addition to providing expert support for responding to 483s, warning letters, consent decrees, and other notifications from the FDA, we also provide complete remediation solutions that improve your processes and avoid future compliance issues. From leadership and project management to tactical execution, we provide all the expert resources you need to react swiftly and thoroughly.

Regulatory Compliance in the EU

The regulatory landscape in the EU may be changing underfoot, but the RQM+ team stays on solid ground with proactive solutions. Whether you are in the process of certifying a new device or transitioning existing products to new regulations, we minimize nonconformities. When a nonconformity report does arise, we guide you through it and make improvements at the same time.

Global Regulatory Compliance

Our seasoned global team is available and ready to travel when you face compliance issues in any market. 

We are passionate about your success. Tell us more about your needs so we can help.

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