MDx CRO

Overview

MDx CRO is a specialist contract research organization and regulatory consultancy serving the in vitro diagnostics (IVD), medical device, and precision medicine sectors. According to the company website, it supports clients from early development through post-market activities, with a focus on IVDR, MDR, ISO standards, MHRA, CE marking, and FDA requirements.

Services

• Clinical research (CRO): Performance studies and clinical investigations under ISO 20916 and ISO 14155, including protocol design, monitoring, data management, eCRF, biostatistics, submission support to ethics committees and competent authorities, and IVD clinical evidence generation (PEP, PER, PMPF, APR, SVRs).
• Precision medicine and companion diagnostics: Clinical and regulatory strategies for CDx development, with stated expertise in oncology, rare diseases, and multi-omic approaches.
• Clinical trial assays and translational medicine: Assay design, analytical validation, regulatory planning, biomarker strategy, and early-phase clinical trials across therapeutic areas.
• Regulatory affairs and technical documentation: IVDR and MDR compliance strategies, CE marking, UKCA submissions, FDA and MHRA coordination, technical documentation, UDI, and GSPRs.
• Quality and compliance: QMS development (ISO 13485, ISO 15189, 21 CFR 820), quality audits, ISO 14971 risk management, and software and spreadsheet validation.
• Regulatory representation: EU Authorised Representative for non-EU manufacturers, UK Responsible Person for non-UK manufacturers, and Legal Representative for clinical studies under IVDR and MDR.
• Training: Courses on IVDR, MDR, ISO 13485, ISO 14971, ISO 15189, ISO 20916, and GCP, plus notified body readiness and bespoke training on IVD design and companion diagnostics.

Sectors served

• IVD manufacturers
• Companion diagnostics and precision medicine developers
• Medical device manufacturers
• Software, digital health, and AI companies (SaMD classification, IEC 62304, usability, and cybersecurity under MDR/IVDR and the AI Act)
• Laboratories (ISO 15189 compliance and laboratory-developed test workflows)

Company-reported highlights

The website reports more than 100 multi-country study submissions, over 600 essential study documents developed, 200+ projects completed, and 500+ devices placed on the market. It also states a 100% success rate in performance study submissions, a 9.4/10 overall client satisfaction rating, and a 90%+ repeat business rate. Offices are listed in Barcelona, London, Madrid, and Lisbon, with regulatory experts across Europe, North America, and APAC. The company describes full digital workflows, including eCRF, eTMF, biostatistics, and real-time reporting.