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NAVIGATE AND FILTER
THE IVDR AND MDR
Our new series of interactive tools allow you to easily filter lines of the IVDR and MDR by topic, chapter, section, article, and any search term. Many of our experts have this tool open at all times on their computers for quick access and it's been a game changer. Now we're sharing them with you!
What RQM+ Can Do for You
Whether you need occasional support with product strategies or a dedicated team that handles all of your regulatory and quality needs, our team is here for you.
Our experts are collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations. With former FDA and EU regulators on staff, our team is ready to work with yours to evaluate risk, prioritize the most impactful products, and implement a plan that makes sense for your business.
RQM+ delivers transformative solutions. The results speak for themselves.
RQM+ was born from a desire to provide high-value transformative solutions for our clients with regulatory and quality needs. Our resources are our biggest asset and we heavily invest in ongoing learning and development.
Regulatory Insights
In The Trenches
Industry Leaders
Committee Participation
RQM+ provides worldwide and industry-leading regulatory and quality consulting and engineering for medical devices and IVDs.
Regulatory Affairs
RQM+ has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product to market. What's more, we're using the MDR and IVDR to make positive business impacts and set your organization up for greater success.
Explore Medical Device Regulatory Affairs
Quality Management Systems
RQM+ uses a customized, business-balanced approach alongside proven best practices to develop and optimize quality systems. Our dedicated global audit team has you covered, from internal and supplier audits to mock FDA inspections.
Explore Quality Management Systems
Explore Audits and Inspections
Design Quality Engineering & Manufacturing QA
Our design assurance, risk management, and manufacturing quality experts help you create and manufacture the best possible device and stay competitive, while also ensuring compliance to the latest regulations.
Regulatory Compliance
RQM+ provides an all-encompassing compliance solution that includes strategic leadership, program management, and a tactical team to address all challenges. These include FDA 483s, warning letters, consent decrees, and notified body non-conformity reports. No challenge is too big.
Post-Market Surveillance
Requirements for PMS deliverables have drastically grown thanks to the MDR and IVDR. RQM+ has extensive thought leadership and expertise in creating PMS, PSURs, and PMCF/PMPF plans, along with developing and executing user surveys. Successful integration of PMS, CERs and PERs, and risk management is a key to success.
Clinical Regulatory Affairs
RQM+ CERs and PERs are like no others. Led by Dr. Amie Smirthwaite, recent global head of clinical compliance at BSI, our team provides comprehensive clinical regulatory strategies including an accurate assessment of sufficient clinical performance data and effective strategies for filling in the gaps to enable CE marking.
Explore Clinical Evaluation Plans/Reports (CERs)
Explore Performance Evaluation Plans/Reports (PERs)
We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.
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