End-to-End IVD CRO Services for IVDR & FDA
From regulatory strategy and assay development to clinical validation, CE marking, and post-market support — MDx CRO is your IVD CRO partner across the full lifecycle.
End-to-End IVD CRO Expertise for Market Success
We guide IVD manufacturers through every phase — from concept and product development to IVDR and FDA compliance, clinical validation, and post-market monitoring. Whether you’re launching a new assay, IVD instrument or updating technical documentation, our IVD CRO ensures compliance, speed, and global market readiness.
Our teams integrate regulatory, analytical, clinical, and biostatistics expertise under ISO 20916 to de-risk programs and accelerate approvals.
RA & Technical Documentation
Comprehensive support from strategy to submission and post-market compliance
• Regulatory Strategy & Market Pathway Definition
• IVD Classification, GSPRs & ISO 14971 Risk Management
• CE Marking & Notified Body Engagement
• 510(k), PMA & Global Regulatory Submissions
• EUDAMED Registration & UDI Consulting
• Design History Files (DHF) & Technical Documentation
• Performance Evaluation Plans (PEP) & Reports (PER)
• Clinical Evidence & Scientific Validity Reports (SVRs)
• Summary of Safety & Performance (SSP)
• Labelling & IFU Development
• Post-Market Surveillance (PMS, PMPF, PSURs)
IVD Analytical Studies
End-to-end support for assay design, verification, and analytical validation
• Analytical Validation Planning
• IVD Product Development & Assay Validation• Biomarker & Molecular Assay Development (PCR, LFA, NGS)
• Analytical Performance Reports (APR)
• CLSI Compliance
• Stability Studies
IVD Clinical Studies
Full-service support for clinical performance evaluation
• Study & Protocol Design
• Clinical Performance Studies & Site Management
• IVD Study Monitoring
• Biostatistics & Data Management
• eCRF & eTMF Design
• ISO 20916 Compliance
Usability Engineering & Human Factors
Designing for user safety and compliance across all IVD formats
• IEC 62366 Compliance
• Formative & Summative Usability Testing
• Usability Protocols & Label Comprehension Studies
• Usability Studies for Point-of-Care IVDs
• Participant Recruitment
Representative Services
EU & UK market access through local representation
• EU Authorised Representative (EC Rep)
• UK Responsible Person (UK RP)
• Interface with Authorities & Notified Bodies
• Labeling & Vigilance Support
Our IVD CRO: From Concept to Market
Define regulatory pathway, device classification, and regional market strategy.
Design and validate your assay, software, or IVD product for analytical and functional performance.
Plan and execute clinical performance studies in alignment with ISO 20916, IVDR and FDA requirements.
Compile IVDR technical documentation or FDA design history file, including labeling and risk analysis.
Prepare and submit dossiers for CE marking, 510(k), or PMA, and support notified body or FDA interactions.
Maintain compliance through PMS, PSURs, PMPF studies, and EUDAMED/UDI reporting.
Our IVD Expertise
As a specialized IVD CRO, we support multiple scientific areas, applications, and technologies.
Scientific Areas
Applications
Technologies
Who We Support as an IVD CRO
Early-stage diagnostic innovators & start-ups
Global IVD manufacturers
Precision Medicine companies
Digital health & AI companies
US companies seeking EU IVDR access
Pharma & Biotech companies developing CDx
LDT to IVDR transition + CE mark for an NGS Clinical Exome Sequencing (CES) panel targeting over 4000 genes
Full technical documentation development for NGS, bioinformatics pipeline, 13485 QMS implementation and notified body submission
CE mark granted in 16 months, enabling the client to become one of the very few laboratories globally to certify such a comprehensive gene panel under IVDR
Frequently Asked Questions
Ask Us a Question-
How does an IVD CRO run ISO 20916 clinical performance studies?
We scope endpoints and study design, develop protocols and eCRFs, qualify sites, monitor conduct, manage data and biostatistics, and compile clinical evidence for the performance evaluation report. Our approach aligns with IVDR Annex XIII/XIV and Notified Body expectations.
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What does an IVD CRO do?
An IVD CRO designs and executes analytical and clinical performance activities, prepares technical documentation, and supports IVDR and FDA submissions. At MDx CRO, we integrate regulatory, biostatistics, site management, and quality to deliver ISO 20916-compliant evidence for CE marking and U.S. approvals.
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Are clinical studies required for EU IVDR compliance?
Not always. Under EU IVDR, clinical performance must be demonstrated through one or more of the following sources:
- Clinical performance studies (Annex XIII & Annex XIV),
- Scientific literature relevant to the device’s intended purpose, or
- Published experience from routine diagnostic use.
Manufacturers must plan this evidence in the Performance Evaluation Plan (PEP) and summarize it in the Clinical Performance Report (CPR) and Performance Evaluation Report (PER). While not all IVDs require a new clinical study, at least one of these sources must be available and sufficient to support the claimed clinical performance.
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Can MDx support LDT-to-IVD transitions?
Yes, we help labs and test developers convert LDTs into compliant IVDs with support on documentation, validation, and market pathway selection.
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How long does CE marking typically take?
Most clients reach CE mark readiness within 6–18 months depending on risk class, data readiness, and notified body availability.
Bring Your IVD to Market—Faster and Compliantly
Whether you are developing a lateral flow assay, preparing for CE mark, or planning an IVD clinical study, our IVD CRO delivers the end-to-end services you need for global success.
