MedTech Clinical Solutions
Accelerate Your MedTech Trials, From Design to Global Submission
MDx delivers expert-led, ISO 14155/20916-compliant clinical research and investigations for IVDs and medical devices—supporting MDR, IVDR, FDA IDE, and global approvals
Your MedTech CRO Partner
At MDx, we offer end-to-end clinical solutions for both IVD and medical device manufacturers. From protocol design and feasibility to regulatory submissions and monitoring, we ensure clinical success—faster, smarter, and globally compliant.
Trusted by global sponsors including top 10 IVD and MedTech manufacturers.
If you are comparing clinical partners, use our medical device CRO qualification checklist to assess relevant experience, quality systems, staffing, data controls and oversight before issuing an RFP.
Why Sponsors Choose MDx
- ISO 14155 / ISO 20916 Clinical Operations
- Full-service EU MDR, IVDR, and FDA IDE support
- Delegated sponsor & EU Legal Representative
- In-house monitoring, biostats, data management
- eCRF, eTMF, QMS & audit readiness
Sponsors evaluating a clinical investigation partner should verify how ISO 14155 is implemented across study planning, monitoring, safety reporting, data management and oversight. Our ISO 14155 CRO qualification guide lists the evidence and questions to include in the assessment.
Our Clinical Services
For help determining whether a proposed study falls under MDR Article 62, Article 74 or Article 82, see our MDCG 2021-6 Rev. 1 clinical investigation guide.
For EU medical device investigations, regulatory compliance also requires a defined process for SAE and device-deficiency reporting. Our overview of MDCG 2020-10/1 safety reporting explains the applicable reporting criteria, timelines and competent authority submission process.
The application package must also include an Investigator’s Brochure that presents device, evidence and risk information in a clear, balanced and traceable form. Use our MDCG 2024-5 Investigator’s Brochure checklist before submission.
Strategy & Planning
Execution & Oversight
Regulatory & Compliance
Usability & Human Factors
| CRO Services |
|---|
| Clinical Project Management |
| Protocol Development |
| Regulatory Support (MDR & IVDR) |
| Study Audits (ISO 14155 / ISO 20916) |
| EU/UK Legal Representative |
| Biostatistics & Data Management |
| eTMF & eCRF Tools |
| Clinical Compliance |
| SOPs for GCP, ISO 14155 & ISO 20916 |
| Multilingual Clinical Team |
| Expertise & Stakeholder Engagement |
| MDR, IVDR, FDA, CA Strategy |
| Complex High-Risk Device Experience |
| Software as a Medical Device (SaMD) Expertise |
| EU Engagement (EMA, MDCG, Notified Bodies) |
| MDx | Other CROs |
|---|---|
 Yes |  Yes |
| In-house expertise |  Often outsourced |
| Specialized support | Generalist support |
| Conducted by MDx experts |  Rarely offered |
| Included | Limited availability |
| Fully in-house | Often outsourced |
| Certified systems | Limited |
| Robust & harmonized | Partial |
| 14+ Languages | Limited coverage |
| Proven track record | Partial |
| Extensive | Limited |
| Specialized | Rarely supported |
| Active participation | No direct access |
Therapeutic Areas & Technologies
Therapeutic Expertise
Technologies
Our Clinical Impact
- 100% success rate in IVDR & MDR study submissions
- 30+ complex trials managed for Class II/III and high-risk IVDs
- 60+ IVD performance study submissions across Europe
- SaMD and digital therapeutics fully managed through to submission
Project Types We Manage
IVD Performance Studies
Medical Device Clinical Investigations
Frequently Asked Questions
Ask us a Question-
Do you manage both IVD and Medical Device studies?
Yes — across MDR, IVDR, FDA IDE, IRB, and more.
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Can MDx act as Legal Representative in the EU?
Yes — under MDR (Art. 62.2) and IVDR (Art. 58.4), we can act as legal rep or delegated sponsor. We also provide UK RP services.
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Do you support software as a medical device (SaMD)?
Yes. We support digital therapeutics, diagnostics, and SaMD studies with IEC 62366-aligned usability testing and FDA Human Factors guidance.
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What’s the difference between a clinical trial, investigation, and performance study?
Clinical trial = general term
Clinical investigation = for medical devices
Performance study = for IVDs
We support all — from feasibility to full submissions.
Partner with a Proven Clinical CRO
Your Clinical Goals. Our Regulatory Precision.
Whether you’re launching a complex IVD study or preparing for global submissions, MDx is your full-service CRO for high-impact clinical outcomes.
Your Device. Our Expertise. Global Impact.
