Company intelligence
MDx CRO
IVD & Medical Device CRO | IVDR · MDR · FDA | Clinical Investigations, Regulatory Affairs, CDx & NGS
About MDx CRO
MDx CRO is a specialised CRO for in vitro diagnostics (IVD), medical devices and precision medicine, supporting manufacturers across the EU, UK and US markets. We combine clinical research and regulatory affairs under one mandate: clinical investigations and IVD clinical performance studies, IVDR and MDR conformity, FDA submissions and QMSR readiness, companion diagnostics (CDx), NGS-based assays, software as a medical device (SaMD) and usability engineering. What we do · Clinical investigations under MDR and ISO 14155, and IVD clinical performance studies under IVDR and ISO 20916 · Regulatory strategy, technical documentation and notified body submissions for IVDR, MDR and UKCA · FDA pathways for IVDs and medical devices: 510(k), De Novo, PMA, IDE and QMSR transition · Companion diagnostics and combined drug-diagnostic programmes at the CTR–IVDR interface · NGS and molecular assay validation strategy, including large panels · Quality management systems (ISO 13485), biocompatibility (ISO 10993-1) and usability engineering (IEC 62366-1) · EU Authorised Representative, UK Responsible Person and Legal Representative for clinical studies Who we work with Global IVD manufacturers, pharmaceutical companies entering diagnostics, and MedTech start-ups and scale-ups, from first-in-human through to post-market surveillance. Why teams choose MDx CRO · 15+ years of experienced experts across medical technologies · 100+ clinical evaluations and IVD performance studies delivered · 500+ completed regulatory and clinical projects · 40+ combined clinical trial and companion diagnostic programs · ISO 13485 certified for regulatory affairs, clinical affairs and quality management services · A 100% authorization rate on clinical study submissions to date Offices in Spain, Portugal and UK, working with sponsors worldwide. Talk to us: contact@mdxcro.com · www.mdxcro.com
Verified activity
Signals from MDx CRO
8 published signals
Research & Knowledge
MDx CRO highlighted that the MDR transitional period for eligible legacy devices ends on 31 December 2027 for Class III and certain Class IIb implantable devices, and on 31 December 2028 for other covered device categories.
Reported by MDx CRO
Research & Knowledge
MDx CRO published recent data from Team-NB's 2025 Medical Device Survey, highlighting that 25,978 MDR applications were reported by Team-NB members by the end of 2025, compared with 13,953 MDR certificates issued, with 81% of survey responses placing the average timeline for a new MDR certificate at 13 months or more.
Reported by MDx CRO
Research & Knowledge
MDx CRO noted that Team-NB reported an 8% decrease in internal conformity-assessment staff and 21% fewer subcontractors in 2025, marking the first decline in internal assessment staffing in more than a decade.
Reported by MDx CRO
Research & Knowledge
MDx CRO published an article analyzing 10 companies turning growth trends into actual products for the Medical Device Market in 2026.
Reported by MDx CRO
Research & Knowledge
MDx CRO published an article examining how parallel pathways interact and which decisions should be resolved before the first submission.
Reported by MDx CRO
Legal & Regulatory
MDx CRO achieved ISO 13485 certification.
Reported by Carlos Galamba
Legal & Regulatory
MDx CRO achieved ISO 13485 certification for its regulatory affairs, clinical affairs, and quality management services across the global Medical Device and In Vitro Diagnostic sectors.
Reported by MDx CRO
Research & Knowledge
MDx CRO published an article examining six trends through the work of 16 French MedTech startups and scale-ups, including companies active in AI-assisted procedures, surgical robotics, active implants, augmented reality, therapeutic ultrasound, and other emerging medical technologies.
Reported by MDx CRO