Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market.

    Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our:

    • Regulatory and Quality Consulting​
    • Lab Services (Jordi Labs)​
    • Clinical Trials​
    • Reimbursement​
    • Technology Solutions
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    Ready for the upcoming PFAS restrictions? We can help.

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    Jordi Labs, an RQM+ Company, has built its E&L business on a foundation of 40+ years as polymer experts and has 10+ years’ experience working specifically with PFAS materials.

    • Supported a customer study for three years to develop a novel fluorinated polymeric system
    • Specialize in tackling the most difficult method development studies for complex sample matrices and analytes
    • Can achieve low level quantitation in the ppb to ppt range
    • Design and perform complex device extraction studies for unique applications
    • Utilize triple quad LC-MS & GC-MS along with Combustion Ion Chromatography to determine total Fluorine content
    • Over 80 analytical techniques available and utilized to provide chemical data and structure
    In addition to lab testing, RQM+’s RA/QA Consulting Services team can help you evaluate suppliers, implement device changes and testing, and complete regulatory submissions associated with the upcoming PFAS phase-out.

    • Supplier support: RQM+’s quality assurance engineers review material lists, setup suppliers, and support the design change process. Our regulatory affairs consultants provide change assessments to determine the scope and regulatory impact of any changes.
    • Testing and validation support: RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed and our project management team oversees the project for you.
    • Regulatory submissions: RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies.

    Watch PFAS Presentation and PanelRead our Technical Brief


    Be Your Best at RQM+

    We give talented professionals a supportive and flexible environment to strategically grow their careers. 

    Click here to view our open positions.


    RQM+ Acquires Germany Based CRO Kottmann

    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.

    Read the press release


    RQM+ Launches Fern.ai™

    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.

    Read the press release


    RQM+ Launches Reimbursement Services

    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.

    Read the press release


    Unmatched regulatory expertise

    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.

    What RQM+ Can Do for You

    Whether you need occasional support with product strategies or a dedicated team that handles all of your commercialization needs, our team is here for you.

    Path

    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.

    1,000+ Clients
    5,000+ Completed Projects
    9.6 Average Net Promoter Score
    90% Repeat Business Rate

    learning-development

    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+ is the leading, global MedTech CRO offering consulting, clinical trial, lab and reimbursement services to support the entire product lifecycle.

    RA/QA Consulting Services

    RA/QA Consulting Services

    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.

    Explore Medical Device Regulatory Affairs

    Explore In Vitro Diagnostics Regulatory Affairs

    Explore Quality Management Systems

    Explore Post-Market Surveillance for Medical Devices

    Explore Post-Market Surveillance for In Vitro Diagnostics

    Lab Services

    Lab Services

    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.

    Explore Lab Services

     

    Clinical Trial Services

    Clinical Trial Services

    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.

    Explore Clinical Trial Services

    Reimbursement Services

    Reimbursement Services

    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.

    Explore Reimbursement Services 

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

    Book a Consultation

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