Medical Devices Expertise | The MedTech CRO

RQM+ provides deep regulatory, quality, clinical, testing, and reimbursement expertise across the entire life cycle of medical devices from early concept development to post-market surveillance. Whether you’re launching a novel device, expanding into new geographies, or addressing complex regulatory requirements in the U.S., EU, or globally, our MedTech-only team offers tailored solutions to de-risk development, accelerate submission, and support global market access.

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Why RQM+ for Medcal Devices?

MedTech CRO

100% focused on medical devices, diagnostics, and combination products.
Integrated CRO Support

Seamless regulatory, quality, clinical, and lab expertise from strategy through execution to global trial operations.
Jordi Labs

Comprehensive analytical and chemical testing including E&L, deformulation, and material investigations.
Flexible Service Models

Full-service outsourcing, professional consulting, and embedded staffing.

Therapeutic Expertise

Cardiology

Oncology

Neurology

Women’s Health

Orthopedics

General Surgery

Wound Care

Urology

Ophthalmology

Infectious Disease

Spine

Life Cycle Support Highlights

Expand each to see key services.

Global regulatory, clinical, and reimbursement strategy for US FDA, EU MDR/IVDR, UKCA, and other global markets
FDA Q-Submissions, Breakthrough Device Designation, and Safer Technologies Program support
Biocompatibility strategy and early verification planning (ISO 10993)
Software-enabled device strategy and design-phase documentation planning
HTA preparedness, early market access modeling, and indication alignment

QMS development, harmonization, and remediation (ISO 13485, 21 CFR 820, MDSAP)
Design Controls and technical file creation
Risk Management Plans (ISO 14971)
Software and cybersecurity documentation (IEC 62304, FDA, IMDRF, MDCG)
Device classification strategy and regulatory pathway mapping
Labeling strategy and UDI planning

Verification and validation planning and execution
Software validation planning and summary documentation (IEC 62304 compliant)
Process, packaging, and sterilization validation (IQ/OQ/PQ)
Human Factors and Usability Engineering validation
Analytical method development and validation (Jordi Labs)
Toxicological risk assessment (per ISO 10993-17)
Extractables & Leachables (E&L), chemical characterization, and material analysis (Jordi Labs)

Clinical strategy, literature reviews, and gap analysis
Protocol and ICF development
Feasibility, site qualification, and startup
Clinical trial execution (FIH, Pilot, Pivotal) and global monitoring
TMF setup and audit readiness
Data management, medical writing, and statistical support
Adverse event reporting and safety monitoring
Clinical evaluation strategy for software-enabled products
PMCF study design and retrospective chart reviews

510(k), De Novo, PMA, IDE, IND submissions
CE Marking technical documentation and EU MDR/IVDR submissions
Clinical Evaluation Reports (CER), Systematic Literature Reviews (SLRs), and Summary of Safety and Clinical Performance (SSCP)
Global dossier preparation, labeling review, and UDI submissions
Notified body and FDA interaction support
Regulatory support for combination products

Regulatory & Quality Overview

U.S. reimbursement strategy (CPT, HCPCS, DRG)
EU market access (NUB, NICE, G-BA) and HTA dossier support
Coding, coverage, and payment strategy development
Global pricing strategy and budget impact modeling
Value communication and payer engagement
Claims support and post-approval reimbursement optimization

Reimbursement Overview

PMS Plans, Reports, and Periodic Safety Update Reports (PSUR)
Post-Market Clinical Follow-Up (PMCF) strategy and execution
Complaint handling and CAPA program support
Incident and adverse event reporting (FDA, EU NCAs)
Recall and field safety corrective action support
Software post-market monitoring and AI model drift detection
Failure investigations and materials deformulation (Jordi Labs)

Global regulatory impact assessments
Submission strategy for new indications, claims, and software versions
New market entry strategy (LATAM, APAC, MEA)
Analytical testing and toxicology support for design or formulation changes (Jordi Labs)
Regulatory due diligence for M&A and licensing
Integration support for acquired product lines

Flexible Partnering Solutions

Full-Service Outsourcing

Comprehensive RA/QA/CA/CRO support.

End-to-end project ownership, from strategy to execution. Our managed outsourcing solutions enable easy collaboration, streamlined operations, and expert oversight so you can focus on what you do best.

Professional Consulting

Project-based or strategic support.

Industry-leading MedTech consultants with the strategic insight and regulatory expertise to solve your toughest challenges. Our global team stays ahead of evolving regulations to keep your innovations moving forward.

Professional Staffing

Embedded regulatory, clinical, and quality talent.

Need an expert or a full team? We provide highly qualified MedTech professionals who integrate quickly and easily into your organization — the right people, right when you need them.

Regulatory, Clinical, Quality, Testing, & Market Access for Medical Devices

Integrated and customized solutions to bring medical devices to patients faster.