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RQM+ is a global MedTech service provider accelerating compliance and market success.
We expedite the entire product lifecycle for medical device and IVD companies, from concept to post-market. Services include:
- Regulatory and Quality Consulting
- Lab Services and Materials Consulting via Jordi Labs
- Clinical Trials
- Reimbursement
- Fern.ai (AI/ML platform)
Unmatched regulatory and quality expertise
With hundreds of industry-best consultants providing end-to-end support worldwide, our collective knowledge and first-hand experience empower us to understand issues and provide specialized, business-balanced solutions. We have deep expertise in all clinical specialties with more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), and notified body regulators than any other firm.
The gold standard in lab services and materials consulting
Jordi Labs, an RQM+ Company, delivers full lifecycle materials science and chemical characterization capabilities to MedTech and other industries. We set the benchmark for extractable-leachable testing, with a reputation for quality acknowledged by the FDA and industry peers. Our expertise spans from conceptual bench top testing and prototyping through design verification and validation, preclinical testing, and post-market lifecycle management.
Powering innovative MedTech clinical trials
RQM+ offers comprehensive clinical trial services with tailored solutions and strategies, specifically designed for the MedTech industry. Our team has deep expertise in trial design and implementation for a wide range of products, including medical devices, in vitro diagnostics, combination device-drug products, and Software as a Medical Device (SaMD). Our capabilities span the spectrum of trial phases, including early feasibility studies, first-in-human, pilot, pivotal (510(k), PMA, and CE Mark), post-market and real-world evidence, and PMCF.
Maximize your returns with reimbursement
RQM+ helps clients maximize the value, recognition, and return on investment for their product technology. Our experts partner with client teams to develop integrated strategies addressing market analytics, market access, payer engagement, health economic data generation, and evidence development required to demonstrate product value and achieve optimal reimbursement positioning.
RQM+ launches Smart Authoring within Fern.ai
Fern.ai's Smart Authoring module revolutionizes MedTech regulatory documentation by automating and streamlining document creation and management. This enhances compliance and accuracy, reducing time-to-market for new products. With a single source of truth, dynamic linking, and robust template management, it ensures consistency and team collaboration. RQM+ uses AI and automation to help manufacturers bring life-saving devices to market faster and with greater confidence.
Be your best at RQM+
We know the success of RQM+ and our employees go hand in hand. Our tagline is the plus is the people, after all. We give talented professionals a supportive and flexible environment to strategically grow their careers, all while advancing global healthcare through MedTech innovation.
Ready for the upcoming PFAS restrictions? We can help.
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
- 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.
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.
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 and the results speak for themselves.
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.
Regulatory Insights
In The Trenches
Industry Leaders
Committee Participation
Former FDA, competent authority, and notified body leadership
Cutting-edge projects, new regulations, and interaction with regulators
Passionate experts, strong professional network, and trusted expertise
Contributions to the content of standards and guidance documents
“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!
Director, Regulatory Affairs
IVDR Implementation Project
Global Medical Device and Diagnostics Manufacturer
RQM+ is a global MedTech service provider offering RA/QA consulting, lab, clinical trial, and reimbursement services to support the entire product lifecycle.
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
Lab Services via Jordi Labs
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.
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.
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.
We are passionate about your success. Tell us more about your needs so we can help.
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