IVD Analytical Validation That Accelerates Global Approval
Expert-led analytical performance studies for IVDR, FDA, and CLSI compliance-covering sensitivity, specificity, stability, and APRs. Unlock faster market access with MDx CRO.
Why Analytical Validation Matters
Analytical validation is the foundation for IVD clinical evidence and regulatory approval. Whether launching a new diagnostic assay or transitioning a legacy product to IVDR, robust analytical performance data is essential for demonstrating assay reliability, accuracy, and safety. At MDx CRO, we deliver analytical studies that meet the highest global standards-ensuring your performance claims are supported, submissions succeed, and timelines stay on track.
- Comprehensive scope: Analytical sensitivity, specificity, accuracy, precision, LoD/LoQ, linearity, and stability studies.
- Regulatory alignment: IVDR Annex I, FDA 510(k)/PMA, and CLSI guidelines (EP05, EP17, EP25, etc.).
- ISO 15189-qualified lab partners and a proven track record with Notified Bodies and the FDA.
Full-Service Analytical Study Design & Execution
MDx CRO delivers end-to-end analytical validation for IVDs
- Regulatory roadmap (IVDR/FDA)
- Analytical Performance Plan
- Protocol development
- Analytical method validation
- CLSI-compliant study design
- Site & lab qualification, project management
- Monitoring,
- Data collection
- Audit readiness
- Analytical Performance Report (APR)
- IVDR evidence packages
- FDA Q-submission support
- PCR
- NGS
- IHC, immunoassays
- Multiplex
- Lateral flow
- SaMD
- and more
- Analytical validation processes
- IVDR evidence requirements
- Knowledge transfer for sustainable internal capabilities
What We Deliver
Assay Validation Protocols
Stability Study Design
Documentation & Reports
Assay Types Supported
Regulatory Alignment
Your analytical studies are mapped to all key international requirements:
- IVDR Annex I, Chapter II, Part A – Analytical performance requirements
- FDA 510(k), De Novo, PMA – Analytical validation and evidence generation
- CLSI Guidelines – EP05, EP07, EP17, EP25, and more
- ISO 13485 QMS and GSPR (EU)
- ISO 15189 laboratory standards
| Capability |
|---|
| Analytical Method Validation |
| IVDR & FDA Expertise |
| CLSI Guidance Compliance |
| APR Development |
| Assay Expertise |
| Stability Study Design |
| MDx CRO Advantage | Typical CROs |
|---|---|
| Developed in-house, tailored protocols | Often generic |
| Proven record, most technologies | Limited |
| FDA & EU alignment | Partial |
| Full support, IVDR formatting | Rarely offered |
| PCR, NGS, IHC, SaMD, immunoassays, lateral flow, etc. | Technology-limited |
| Real-time & accelerated, full support | Rarely offered |
Results That Matter
- 100% success rate: No major Notified Body findings in analytical study design
- 40+ projects: Analytical performance studies for IVDs, CDx & digital diagnostics
Trusted by top 10 IVD manufacturers, early-stage & mid-sized diagnostic firms
Frequently Asked Questions
Ask us a Question- What is the difference between analytical and clinical validation?
Analytical validation confirms that an IVD accurately, reliably, and consistently measures the analyte of interest (e.g., sensitivity, specificity, precision). Clinical validation assesses how well the test identifies a clinical condition in the target population. Both are required for IVDR and FDA submissions.
- Can MDx help with APR creation and IVDR Analytical Performance Reports?
Yes. We provide full APR development, including statistical analysis, summary writing, and formatting for IVDR and FDA requirements.
- Do you support CLSI-compliant documentation?
Absolutely. Our protocols and reports are aligned with CLSI standards (EP05, EP17, EP25, etc.), ensuring global regulatory acceptance.
- What types of technologies do you support?
We cover PCR, NGS, immunoassays, IHC, multiplex, lateral flow, SaMD, and more.
- How quickly can an analytical validation study be completed?
Timelines depend on assay complexity and sample availability, but most studies are completed in 2–6 months with MDx CRO’s project management.
Ready to Validate Your Diagnostic? The Right Way.
Partner with MDx CRO for high-quality, regulator-ready IVD analytical validation and APR development.
