In Vitro Diagnostics Medical Devices | IVD Regulatory

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.

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Why RQM+ for IVDs?

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

IVD Support Across the Total Product Life Cycle

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

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.

IVDR, FDA, & ISO Support Across the Product Life Cycle

Integrated and customized solutions to bring IVD products to patients faster.

Why RQM+ for IVDs?

MedTech-Only CRO

Regulatory and Clinical Integration

True IVDR Experts

FDA Compliance

Life Cycle Support

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

IVD Support Across the Total Product Life Cycle

Flexible Partnering Solutions

Outsourcing

Consulting

Staff Augmentation

Ready to Simplify IVD Compliance and Accelerate Market Access?