Full-Service Expertise Across MedTech, Diagnostics & Digital Health
Explore our complete CRO and regulatory service portfolio by sector. From IVDR and MDR submissions to global clinical trials and ISO compliance—MDx delivers cross-functional expertise tailored to your technology.
Whether you’re building an AI-powered diagnostic, transitioning a lab-developed test under IVDR, or launching a Class III implantable device, MDx offers both vertical specialization and transversal strength . Browse by sector to see what we do in your space—or explore our complete service list.
Precision Medicine & Companion Diagnostics
We work with diagnostic developers and pharma sponsors to bring biomarker-based and co-developed CDx products to market.
Protocol design and execution for CDx under IVDR Annex XIV, often embedded in combined drug–diagnostic trials. PS authorization and notification.
Development of all device technical documentation required for Performance Study authorization (PSA).
Analytical validation packages for biomarker assays, sequencing-based CDx, and immunoassays.
Legal representative support for CDx performance studies under IVDR in the EU and UK RP services.
Assessment of EU health institution exemption under article 5(5) and due diligence of local tests.
Validation of bioinformatics pipelines for NGS, tumor profiling, germline diagnostics and more.
Literature-based clinical utility assessments for the link between biomarker and targeted therapy.
CDx regulatory readiness, training in performance studies and pharma-collaborative planning under IVDR.
In-Vitro Diagnostics (IVD)
We support IVD developers with end-to-end solutions—from RUO validation through IVDR CE marking and FDA 510(k)/De Novo submissions.
CLSI-aligned analytical verification and performance reporting.
Design and execution of ISO 20916-compliant performance evaluations under IVDR.
Annex XIII-aligned evidence generation with AI-powered literature search.
GSPR checklists, PERs, and full IVDR technical file creation.
Validation of multiplex assays, sequencing workflows, and data pipelines in regulated IVD contexts.
Human factors validation for point-of-care tests and instrument-user interactions under IVDR.
IVDR-compliant QMS development, ISO 13485 implementation, risk management per ISO 14971, and internal audits.
EU AR, UKRP, and IVDR legal representation for performance studies.
IVDR implementation, QMS, and notified body preparation.
Medical Devices
We help manufacturers meet MDR and FDA expectations through clinical validation, documentation, and usability engineering.
ISO 14155-aligned trials, PMCF, and global site management.
IEC 62366-compliant human factors validation for class I-III devices.
CER remediation, MDR Annex II/III file preparation, and labeling compliance.
Risk management per ISO 14971, ISO 13485 audits, and CAPA systems.
MDR representation and UKRP responsibilities for non-EU/UK manufacturers.
MDR readiness, notified body expectations, clinical evidence, and ISO 13485 implementation workshops.
Software, Digital Health & AI
From SaMD and connected diagnostics to AI/ML tools, we support end-to-end digital health compliance under MDR, IVDR, and the upcoming AI Act.
Human factors testing for mobile apps, wearables, and interfaces.
IEC 62304 documentation, risk classification, and CE/FDA pathways.
AI regulation, SaMD guidance, and cybersecurity framework alignment.
Clinical validation of digital therapeutics and AI diagnostics, including evidence generation and trial oversight for regulated software products.
Laboratories
We help hospital, reference, and trial labs align with IVDR Article 5.5 and ISO 15189 while validating in-house assays and ensuring international compliance.
Creation of technical documentation for in-house assays, including justification files, GSPR checklists, and public declarations under Article 5.5 and IVDR
Hybrid QMS development combining ISO 15189 and ISO 13485 standards, audit readiness, and risk-based process design.
IVDR Article 5.5 compliance workshops, ISO 15189 gap assessments, and SOP harmonization for clinical labs.
Full lifecycle support for labs offering diagnostic services—from analytical validation to CE marking and clinical performance studies.
Why MDx?
One CRO. All Verticals. Full-Service Delivery.
- Trusted by Top 10 IVD, Pharma & MedTech companies
- 100% first-time CE mark approvals
- Preferred Training Partner to Top EU Notified Bodies on IVDR/MDR
- Specialists in IVDR, MDR, ISO 13485/15189, and SaMD
