Medical Device Expertise | Regulatory Consulting

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 Medical 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.

Regulatory (US/EU)
- Regulatory strategy development
- Intended use and indication refinement
- Jurisdiction and classification (e.g., 510(k), PMA, EU MDR Rule-based)
- Predicate/reference product analysis
- Risk-based regulatory pathway assessment
Quality
- QMS planning (ISO 13485)
- Supplier qualification strategy
- Risk management framework planning (ISO 14971)
- Design control planning documentation
- Early traceability matrix structure
Clinical
- Early clinical development strategy
- Endpoint identification for feasibility
- Usability and human factors study planning (IEC 62366)
Reimbursement
- Payer landscape and evidence expectations (CMS, HTA bodies)
- Value proposition development
- Coding pathway research (US)
- EU market access early input
Labs (Jordi Labs)
- Preliminary materials compatibility review
- Biocompatibility risk assessment
- Extraction methodology planning (ISO 10993-1)
- Toxicological strategy
Medical Writing
- Regulatory strategy write-up
- Intended use statement development
- Clinical development plan summary
- Value dossier framework draft

Regulatory (US/EU)
- FDA Pre-Sub / Q-Sub support
- EU Scientific Advice support
- Design dossier regulatory reviews
- Drafting device descriptions for regulatory filing
Quality
- Design History File (DHF) documentation
- Traceability matrix and design input/output tracking
- Software development life cycle documentation (IEC 62304)
- Supplier quality documentation
- Risk file construction
Clinical
- Study protocol design (feasibility or pivotal)
- Site engagement and investigator identification
- Human factors formative testing planning
Reimbursement
- Economic model input documentation
- Stakeholder engagement prep (payers, HTA)
- Coding/coverage feasibility
- Pricing planning for target markets
Labs (Jordi Labs)
- Extraction testing protocol review
- Chemical characterization planning
- Batch-to-batch comparison testing strategies
Medical Writing
- Protocol writing
- Investigator Brochure (IB) drafting
- Risk-benefit summaries
- IFU and product description writing

Regulatory (US/EU)
- Test method documentation alignment with regulatory expectations
- Human factors validation support documentation
- FDA pre-sub for validation review
- EU verification reports and risk file updates
Quality
- Support for test method validation documentation
- Risk file closure
- Compliance review of V&V protocols (IQ/OQ/PQ)
- Final DHF/DMR compliance package
Clinical
- Human factors summative testing
- Usability validation
- Device handling and use validation documentation
Reimbursement
- Validation of outcomes-based value messaging
- Clinical value alignment to payer strategy
Labs (Jordi Labs)
- ISO 10993 panel execution documentation support
- Extractables & Leachables study design
- Toxicological risk assessments
- Material certificates and conformance review
Medical Writing
- Validation summary reports
- Clinical validation evidence reports
- Labeling support documentation
- Final usability documentation

Regulatory (US/EU)
- IDE (US) or Clinical Investigation Application (EU) preparation
- Clinical trial regulatory compliance
- Site and sponsor documentation preparation
Quality
- GCP compliance documentation
- SOP development for monitoring and data handling
- Clinical quality management plan
Clinical
- Full-service trial execution (monitoring, data collection, biostatistics)
- Study site training and oversight
- Clinical Study Reports (CSR)
Reimbursement
- Evidence development aligned with coverage expectations
- Early payer discussions (US)
- HTA evidence dossier strategy (EU)
Labs (Jordi Labs)
- Clinical use batch testing
- Study product E&L review
- Shelf-life testing
Medical Writing
- Clinical Protocols and Amendments
- Informed Consent Forms (ICFs)
- Clinical Study Reports (CSRs)
- Investigator Brochures
- Interim analysis summaries

Regulatory (US/EU)
- Device description finalization
- IFU and UDI guidance
- Country-specific registration strategy
Quality
- QMS implementation (ISO 13485, MDSAP prep)
- Internal audit support
- Supplier audit documentation
- CAPA system readiness
- Process validation documentation (support only)
Clinical
- PMCF plan (EU)
- Clinical data use in manufacturing documentation
Reimbursement
- Labeling review to support coverage strategy
- Finalization of payer messaging
Labs (Jordi Labs)
- Final materials testing and compliance
- Packaging and shelf-life testing
Medical Writing
- UDI label content
- Instructions for Use (IFUs)
- PMCF plan narrative
- Technical File content

Regulatory (US/EU)
- FDA: 510(k), De Novo, PMA submissions
- EU MDR: Technical Documentation for NB review
- Global registration document preparation
- Deficiency response drafting
Quality
- Risk file updates
- Audit prep documentation
- Inspection readiness materials
Clinical
- Clinical Evaluation Report (CER)
- Summary of Safety and Clinical Performance (SSCP)
- Trial results summaries
Reimbursement
- Coverage and reimbursement support within submission
- Value story alignment with submission strategy
Labs (Jordi Labs)
- Biocompatibility reports
- Shelf-life data
- Final material declarations
Medical Writing
- Submission module writing (FDA/CE)
- GSPR cross-reference tables
- Executive summaries for submissions
- Deficiency response narratives

Regulatory & Quality Overview

Regulatory (US/EU)
- UDI and EUDAMED submission
- Final IFU, label, and country-specific approvals
- Global registration execution
Quality
- Field action readiness
- Complaint handling SOPs
- Post-market audit support
Clinical
- PMCF study launch
- Real-world data tracking plans
- Registries integration
Reimbursement
- HTA engagement (EU)
- Coverage and coding submissions (CMS/payers)
- Launch toolkit development
Labs (Jordi Labs)
- Launch batch verification
- Final packaging validation (documentation only)
Medical Writing
- PMCF protocol and plan
- Launch content for field teams
- HTA briefing book
- Patient-facing educational content

Regulatory (US/EU)
- PSUR, PMS Reports (EU)
- MDR, Vigilance Reporting (US)
- PMCF Reporting
Quality
- CAPA execution
- Surveillance system updates
- Periodic internal audits
Clinical
- PMCF data collection
- RWE strategy and study execution
- Registry engagement and analysis
Reimbursement
- Real-world outcomes reporting
- Coverage renewal support
Labs (Jordi Labs)
- Ongoing testing for materials/complaints
- Root cause support testing
Medical Writing
- PSUR, PMS, PMCF Reports
- RWE summary briefs
- Post-market analysis and updates

Regulatory (US/EU)
- Change notification strategy (FDA supplements, EU Substantial Changes)
- Regulatory impact assessments
- International expansion registration
Quality
- System harmonization
- Risk file and DMR updates
- Training program documentation
Clinical
- Bridging studies and comparative studies
- PMCF updates
Reimbursement
- Value messaging updates for new claims
- Pricing strategy updates for new geographies
Labs (Jordi Labs)
- New material characterization
- Equivalence analysis
Medical Writing
- Change impact summary
- Updated IFUs and CERs
- Submission module updates

Regulatory (US/EU)
- 483 / Warning Letter response strategy
- Notified body audit findings remediation
- Regulatory crisis management
Quality
- Emergency audit prep
- SOP development and QMS corrections
- Field safety corrective action documentation
Clinical
- Clinical hold remediation
- Urgent study redesign
- Unplanned PMCF needs
Reimbursement
- Crisis-based payer messaging
- Coverage re-engagement
Labs (Jordi Labs)
- Root cause failure testing
- Rapid tox reanalysis
Medical Writing
- Emergency response narratives
- CAPA documentation
- Rapid CER/SSCP updates

Flexible Partnering Solutions

Outsourcing

Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. Partner with us.

Consulting

Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+
consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. Partner with us.

Staff Augmentation

Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand
professionals, functional service support, fast deployment for tight timelines, and
contract-to-hire options that integrate seamlessly with your team. Match with a contractor.

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

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