MDx CRO achieved ISO 13485 certification.

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

Founded 2021