RQM+ provides deep regulatory and clinical expertise for in vitro diagnostic (IVD) manufacturers, with fully integrated support across EU IVDR and U.S. FDA requirements. From strategic planning through post-market performance follow-up (PMPF), our MedTech-only team helps de-risk development, accelerate submissions, and support global market success

  • MedTech-Only CRO

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

  • Regulatory and Clinical Integration

    End-to-end alignment across regulatory strategy, clinical performance, and market access.

  • True IVDR Experts

    Scientific validity, classification, PERs, and compliance with Annexes I, XIII, and XIV.

  • FDA Compliance

    U.S. regulatory strategy aligned with 21 CFR Parts 807, 809, 812, 820, and more.

  • Life Cycle Support

    From design through post-market surveillance and notified body audits.

Standards We Navigate

  • EU IVDR (Regulation EU 2017/746)

  • ISO 13485 – Quality Management Systems for Medical Devices

  • ISO 15189 – Medical Laboratories – Requirements for Quality and Competence

  • ISO 20916 – Clinical Performance Studies of IVDs

  • FDA 21 CFR Parts 11, 50, 56, 58, 807, 809, 812, 820

  • CLSI EP Series Guidelines (e.g., EP05, EP07, EP09)

  • GDPR and IVDR Article 61 – Data protection in EU clinical research

Expand each to see key services.

  • Regulatory (US/EU)
    • Intended use statement refinement (US: 510(k), De Novo, PMA / EU: IVDR classification A–D) 
    • Regulatory pathway determination 
    • Companion diagnostic vs. standalone diagnostic determination 
    • Risk classification analysis under IVDR and FDA guidance 
    • Jurisdiction and technology type assessment (e.g., NGS, PCR, antigen-based) 
  • Quality
    • QMS planning (ISO 13485, IVDR-specific requirements) 
    • Design control strategy 
    • Risk management framework aligned to IVD-specific hazards 
    • Supplier evaluation and selection planning 
  • Clinical
    • Analytical vs. clinical performance study planning 
    • Early clinical evidence generation roadmap 
    • Companion diagnostic biomarker validation requirements 
  • Reimbursement
    • Coverage landscape for diagnostic category 
    • Coding and payment feasibility assessment (CPT/PLA/HCPCS in US) 
    • HTA and evidence expectations (EU) 
    • Preliminary value proposition outline 
  • Medical Writing
    • Regulatory strategy brief 
    • Preliminary Intended Use and claims language 
    • Value proposition outline 
    • Development of initial analytical/clinical performance plans 
  • Regulatory (US/EU)
    • FDA pre-submission package (e.g., Q-Sub, IDE) 
    • EU Scientific Advice engagement 
    • Labeling and IFU content guidance 
    • Classification and grouping strategy under IVDR 
    • Software as part of IVD (SaMD) pathway alignment 
  • Quality
    • Design History File (DHF) preparation 
    • Traceability matrix from requirements to testing 
    • Risk management file development 
    • Supplier quality documentation 
    • Reagent manufacturing control documentation 
  • Clinical
    • Clinical performance study design (e.g., prospective, retrospective, bridging) 
    • Analytical protocol development (sensitivity, specificity, LoD, etc.) 
    • Comparator selection and justification 
    • Site/investigator alignment 
  • Reimbursement
    • Evidence strategy development for payers and HTA 
    • Clinical utility study planning 
    • Economic modeling inputs 
    • Strategy for obtaining proprietary codes or PLA codes 
  • Medical Writing
    • Protocol writing (analytical and clinical) 
    • Labeling and IFU content 
    • Drafting risk-benefit narrative 
    • Early technical documentation for IVDR 
  • Regulatory (US/EU)
    • Analytical validation summary documentation support 
    • FDA alignment for LoD/LoQ studies 
    • EU verification report preparation per IVDR Annex II 
    • GSPR mapping 
  • Quality
    • Verification & validation test protocol support 
    • Documentation for analytical software testing (for software-enabled IVDs) 
    • Risk file finalization 
    • Support for verification method documentation 
  • Clinical
    • Clinical performance study execution support 
    • Comparator analysis documentation 
    • Sample size justification and statistical plan validation 
  • Reimbursement
    • Aligning performance claims with economic messaging 
    • Demonstrating clinical relevance of endpoints for payer acceptance 
  • Medical Writing
    • Analytical and clinical validation summary reports 
    • Study protocol amendments 
    • CER performance summary 
    • Labeling refinements 
  • Regulatory (US/EU)
    • Clinical performance study management support 
    • Support for IDEs (US) and Clinical Performance Study Applications (EU) 
    • Clinical trial compliance documentation 
    • Consent and ethics review documents 
  • Quality
    • Monitoring SOPs and GCP compliance 
    • Clinical site quality documentation 
    • Data integrity controls for sample tracking 
  • Clinical
    • Full-service clinical trial execution 
    • Data management and statistical analysis 
    • Interim analyses and enrollment tracking 
    • Study site monitoring 
  • Reimbursement
    • HTA dossier input strategy (EU) 
    • Integration of clinical evidence with payer-required outcomes 
    • Planning for post-trial economic modeling 
  • Medical Writing
    • Clinical performance protocols 
    • Informed Consent Forms (ICFs) 
    • Interim and final Clinical Study Reports (CSRs) 
    • Patient narratives or case reports (if needed)
  • Regulatory (US/EU)
    • Labeling and UDI prep 
    • Country-specific registration planning 
    • Instructions for Use (IFU) finalized per IVDR Annex I 
  • Quality
    • QMS implementation (ISO 13485, IVDR Annex IX) 
    • Manufacturing process documentation 
    • Supplier audit documentation 
    • CAPA system and field readiness processes 
  • Clinical
    • PMPF planning (EU) 
    • Stability studies for performance impact 
  • Reimbursement
    • Alignment of launch label with payer-relevant claims 
    • Launch price justification documentation 
    • US: coding and coverage planning 
  • Medical Writing
    • Final Instructions for Use (IFU) 
    • Launch-ready GSPR checklists 
    • PMPF plan write-up 
    • Labeling for global submissions 
  • Regulatory (US/EU)
    • FDA: 510(k), De Novo, PMA or Dual 510(k)/CLIA submissions 
    • EU: IVDR Technical Documentation (Annexes I, II, III, IX) 
    • GSPR crosswalk development 
    • IFU and UDI compliance 
  • Quality
    • DHF/DMR audit-ready review 
    • SOP readiness 
    • Final traceability documentation 
  • Clinical
    • Final CER with analytical and clinical evidence 
    • Summary of Safety and Performance (SSP) 
    • Performance claims substantiation 
  • Reimbursement
    • Reimbursement strategy integration into submission 
    • HTA document coordination 
    • Pre-sub alignment with CMS (US) or HTA (EU) 
  • Medical Writing
    • Submission module writing (FDA/IVDR) 
    • CER and SSP writing and formatting 
    • Deficiency response letters 
    • Labeling narrative summaries
  • Regulatory (US/EU)
    • Registration execution (FDA, EU NB, global) 
    • UDI and EUDAMED support 
    • Country labeling variations 
  • Quality
    • Complaint handling SOPs 
    • Surveillance process documentation 
    • Notified body / competent authority audit prep 
  • Clinical
    • PMPF study initiation 
    • RWE program planning 
  • Reimbursement
    • Reimbursement code submission 
    • Engagement with HTA bodies 
    • Development of launch market dossiers 
  • Medical Writing
    • PMPF protocols 
    • Launch support materials for access teams 
    • Health economics summaries 
    • Payer education content 
  • Regulatory (US/EU)
    • PMS reports, PSURs, PMPF Reports (EU) 
    • Vigilance and adverse event reporting 
    • CAPA regulatory support 
  • Quality
    • Audit support and system monitoring 
    • Complaint investigations 
    • Change control documentation 
  • Clinical: 
    • PMPF execution and analysis 
    • RWE capture strategy 
    • Registry participation (if applicable) 
  • Reimbursement
    • Evidence updates to support continued reimbursement 
    • Annual review of coverage and payer support tools 
    • Troubleshooting batch variation 
  • Medical Writing
    • PSURs and PMPF reports 
    • RWE summaries 
    • CER updates 
    • Surveillance narrative reports 
  • Regulatory (US/EU)
    • EU: Substantial Modification review under IVDR 
    • US: Special/Panel-track supplement strategy 
    • Global regulatory expansion support 
  • Quality
    • QMS integration for acquired products 
    • Risk file and DHF updates 
    • Updated training documentation 
  • Clinical
    • Clinical bridging study planning 
    • CER updates 
    • Label expansion justification 
  • Reimbursement
    • Global pricing strategy 
    • New indication value messaging 
    • Expansion of economic modeling 
  • Medical Writing
    • Revised IFUs and labeling 
    • Updated CERs 
    • M&A transition documentation 
  • Regulatory (US/EU)
    • Notified body non-conformance response 
    • FDA 483/Warning Letter remediation 
    • Rapid audit preparation 
  • Quality
    • Emergency SOP development 
    • Field action documentation 
    • Quality system triage support 
  • Clinical
    • Clinical investigation remediation 
    • CAPA and study redesign 
    • Post-market corrective study support 
  • Reimbursement
    • Crisis coverage reevaluation support 
    • Engagement with CMS/HTA to mitigate disruption 
  • Medical Writing
    • Emergency update of CERs/SSPs 
    • CAPA narratives and NB responses 
    • Clinical risk assessment documentation 
Full-Service Outsourcing

Full-Service Outsourcing

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

Professional Consulting

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

Professional Staffing

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.

Ready to Simplify IVD Compliance and Accelerate Market Access?

Let RQM+ be your partner for strategy, execution, and compliance — from concept to post-market. We make the complex simple for IVD innovators.

Contact us to schedule a discovery call with our diagnostics team.

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