IVD & Medical Device CRO Services by Therapeutic Area
Specialized support for IVD and medical device clinical trials in oncology, infectious disease, genetics, and cardiovascular medicine. Drive faster approvals through therapeutic-specific regulatory and clinical strategies.
Strategic Therapeutic Area Expertise
At MDx, we specialize in delivering regulatory and clinical research services across diverse therapeutic domains. We understand that each therapeutic area presents its own scientific, clinical, and regulatory challenges. That’s why our approach is built on therapeutic-specific strategies designed to meet the complex demands of high-risk diagnostics and medical devices.
Whether you’re developing an IVD for infectious disease surveillance, a Class III cardiovascular implant, or a next-generation companion diagnostic (CDx), MDx ensures precise regulatory navigation and efficient clinical execution.
IVD Expertise Across Key Therapeutic Areas
Infectious Disease & Immunity
Case Study
A global manufacturer conducting a respiratory PCR IVDR study partnered with MDx. We enrolled across 8 EU sites, achieving early enrollment and 100% data compliance.
Genetic & Genomic Testing
Highlight
We supported a US lab in CE marking an NGS panel for over 4,000 genes, including full tech file, IVDR compliance, and ISO 13485 system buildout.
Cardiovascular & Physiological Markers
Example
Supported validation and clinical performance study for a multi-marker POCT cardiac panel across EU centers with variable workflow environments.
Additional IVD Therapeutic Domains
Alzheimer’s biomarkers, neuroimaging support tools, cognitive function assessments
Thyroid panels, hormonal testing, diabetes screening
Fertility diagnostics, hormone tracking, prenatal screening
Autoantibody panels, cytokine response assays
HLA typing, donor compatibility assays, graft rejection monitoring
CBC panels, transfusion compatibility, safety monitoring
Oncology & Precision Medicine
Oncology and CDx projects comprise 25.5% of our IVD work. Our integrated clinical and regulatory services include:
- NGS tumor profiling and targeted mutation panels
- CDx development per IVDR Annex XIV and FDA co-development guidelines
- Liquid biopsy (ctDNA, CTC) and MRD detection
- IHC/ISH tissue scoring and standardization
- Multimodal diagnostics integrating digital pathology and molecular data
- Regulatory strategy for EMA-FDA-Notified Body alignment
Medical Device Expertise by Therapeutic Area
- Vascular stents, heart valves, Class III monitoring systems
- Remote telemetry & wearable Remote Patient Monitoring (RPM) systems
- EU MDR & FDA Class III submissions with PMCF planning
- Dental implants, surgical guides, intraoral scanners
- ENT diagnostics, cochlear implants, audiometry platforms
- Deep brain stimulation (DBS) systems, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS)
- Neurological software with AI-enhanced scoring algorithms
- Optical Coherence Tomography (OCT), ultrasound, and Magnetic Resonance Imaging (MRI)-compatible devices
- Surgical navigation, image-guided robotics, endoscopic systems
- Oxygen therapy devices, nebulizers, pulmonary function monitors
- Negative Pressure Wound Therapy (NPWT) systems and wound care diagnostics
- Digital therapeutics, SaMD platforms, clinical decision support systems (CDSS)
- Mobile apps, cybersecurity validation, MDSW MDR compliance
- Joint replacement systems, spinal implants, fixation devices
- Class IIb/III implants requiring PMCF and technical documentation
- Intraocular lenses, OCT devices, retinal scanners
- Usability testing and image-based performance assessments
- Continuous glucose monitors (CGM), insulin delivery systems
- Integrated digital platforms and risk management for combination devices
Therapeutic Area Distribution
Diagnostics
Medical Devices
Integrated Therapeutic Support Services
Clinical & Regulatory Strategy
Medical & Scientific Affairs
Therapeutic-Focused Quality & Compliance
Challenge: A US biotech developing an NGS-based CDx needed to conduct a performance study under IVDR to support both EU market access and pharma partnership requirements.
Solution: MDx designed an IVDR Annex XIV-compliant protocol with therapeutic-specific endpoints, managed sample collection across 9 oncology centers, and coordinated with laboratory sites for testing.
Result: Successfully completed sample collection for 3 tumor types within 8 months, with full IVDR-compliant documentation and evidence package.
Challenge: A global manufacturer needed to transition their molecular infectious disease assay from IVDD to IVDR with updated performance claims and expanded intended use.
Solution: MDx implemented a gap assessment, designed a clinical performance strategy compliant with IVDR, and managed sample collection across multiple European countries.
Result: The client achieved IVDR certification with expanded clinical claims, strengthening their market position.
Challenge: A US laboratory sought to CE mark their NGS clinical exome sequencing panel targeting over 4,000 genes under IVDR.
Solution: MDx developed complete technical documentation for the NGS workflow and bioinformatics pipeline, implemented ISO 13485 QMS, and managed the notified body submission process.
Result: CE mark granted in 16 months, enabling the client to become one of the few laboratories globally to certify such a comprehensive gene panel under IVDR.
| Capability |
|---|
| Domain-specialized teams |
| Protocols tailored to indication |
| Specialty lab & site networks |
| Integrated clinical-regulatory-compliance |
| Real-time regulatory intelligence |
| Experience with rare & complex diseases |
| MDx CRO | Typical CROs |
|---|---|
 |  Generalist teams |
|  Templates reused across studies |
| Limited therapeutic reach |
| Siloed expertise |
| Infrequent updates |
| Limited experience |
Client Testimonials
Ask us a Question- How does MDx ensure therapeutic alignment?
We assign domain-specific experts to each project, ensuring your study benefits from deep clinical and regulatory experience in your therapeutic area.
- Can MDx support rare diseases or niche indications?
Absolutely. We have experience with small-population studies and complex inclusion criteria, including pediatric, genomic stratification, and rare biomarker validation.
- How do you manage therapeutic-specific regulatory risks?
Our regulatory team develops custom strategies aligned to therapeutic-specific guidance, standards, and emerging policy.
- What is your global site reach by therapeutic area?
We maintain therapeutic-aligned site networks across North America, EU, and APAC with established relationships for each indication.
- How does MDx stay current on evolving regulations?
Our in-house regulatory intelligence group tracks EU MDR/IVDR, FDA guidance, and therapeutic-specific updates in real time.
Accelerate Your Study. De-risk Your Submission. Deliver Clinical Impact.
Whether you’re advancing a next-gen oncology CDx or launching a respiratory POCT in Europe, MDx provides therapeutic-area-specific expertise to guide your product from concept to certification.
