One of our greatest strengths is the unrivaled collective knowledge our team brings to your projects. There are several factors to consider when choosing a regulatory and quality partner, and one of the most important is evolving expertise.
When your team is overwhelmed, you can trust our committed experts to deliver high-value solutions that exceed expectations.
With these new capabilities, RQM+ provides comprehensive regulatory, quality, clinical and laboratory services, supporting market access throughout the entire product lifecycle for medical devices and diagnostics.
We do more than just regulatory submissions. Our seasoned team works with yours to evaluate risk, prioritize the most impactful products, and implement a plan that makes sense for your business.
We’re a trusted partner that seamlessly integrates with your team to deliver best-in-class regulatory and quality solutions. We’re genuinely here to support our clients with wisdom, expertise, and tailor-made solutions.
We only recruit service-minded people who truly want to help their clients and, ultimately, the patients served. This allows us to deliver solutions that support business success and help clients stay competitive in the marketplace.
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!
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+ 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.
“I am amazed at how much work and the number of decisions that have been made to date on this project! I really appreciate the effort and patience of your entire team! Lots of work to go in 2021, but I am grateful that your team is helping us manage through this process.”
Director, Regulatory Affairs
"IVDR Implementation Project"
Global Medical Device and Diagnostics Manufacturer
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.
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.
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.
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.
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.
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.
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