With 40 years of regulatory expertise, RQM+ has the largest global team of MedTech regulatory and quality consultants. We reduce commercialization risk by offering a full complement of CRO services to get medical devices, digital therapeutics and diagnostics on the market and keep them there. Watch the video below to learn about our multiple business units and differentiated, end-to-end services.
We give talented professionals a supportive and flexible environment to strategically grow their careers.
RQM+ announces its acquisition of CRO Kottmann, a premier contract research organization (CRO) renowned for its excellent customer service, scientific clinical research and quality in the key market of Germany. This significant move further supports RQM+’s dedication to strategic growth and presence in Europe and emphasizes its dominance in the growing areas of MedTech.
Fern.ai is the first offering from RQM+ Technology Solutions and the first human-in-the-loop artificial intelligence (AI) platform that standardizes all aspects of clinical evidence literature review for regulatory affairs professionals – delivering audit-ready, exportable results in 60% less time than a manual process and 40% less time than alternative technology platforms.
We use our extensive experience with the latest reimbursement requirements and value-based compensation models, as well as key payment trends, to provide customized support that fits each company's needs.
With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, RQM+ has deep expertise in all clinical specialties. RQM+ currently serves 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
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+ provides comprehensive, high-quality commercialization solutions to help MedTech manufacturers get their products on the market and keep them there. Our experts are our greatest 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 and keep it there. What's more, we're using the MDR and IVDR to make positive business impacts and set your organization up for greater success.
Through innovative new processes, we provide chemical characterization and complex product deformulation as well as contaminant and failure investigations to MedTech manufacturers. Our team of Ph.D. analytical chemists uses a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements. Additionally, our publications are frequently cited by both regulators and industry.
We use innovative digital tools to ensure industry-leading transparency, speed and agility, which enables MedTech manufacturers to make better data-driven decisions for patients. Our comprehensive suite of CRO services supports clinical trials throughout North America and Europe.
MedTech companies need a team of experts to achieve the right reimbursement strategy — one focused on proper coding, appropriate insurance coverage and adequate payment. Our veteran team includes former health plan executives, physicians, health economists and certified professional coders from the medical technology, biotechnology, pharmaceutical and healthcare industries.
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