MDx CRO Logo - medical devices

MDx CRO

medical devices
China's Best One-Stop Medical Equipment Provider
About

MDx CRO is a specialized Contract Research Organization (CRO) dedicated to the MedTech sector, focusing on medical devices, in vitro diagnostics (IVD), and companion diagnostics (CDx). The company provides a wide range of services that encompass the entire lifecycle of medical products, including research and development, clinical research, regulatory affairs, quality assurance, and post-market activities. MDx CRO aims to simplify the complex processes involved in bringing medical products to market while ensuring compliance with industry standards and regulations. Their expertise includes designing and managing clinical investigations, regulatory strategy consulting for medical device approvals, and quality management system consulting. MDx CRO also offers specialized training to support clients in achieving regulatory readiness and competitive project timelines. They serve a diverse clientele, including pharmaceutical, biotech, and diagnostic companies, helping them navigate regulatory landscapes and accelerate market entry in both European and U.S. markets.

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Keywords
regulatory affairsquality assuranceclinical researchin vitro diagnosticmedical devicetechnical dossiermdrivdriso 14155qmsiso 20916iso 14971iec 62304iec 82304iec 62366technical documentationngscdxinfectious diseasescomplianceiso 13485iso 9001performance studiesiso 15189crogene and cell therapiesclinical trial supportivdr performance study toolkitivdr performance studiesassay development services
Company Information
  • Employees39
  • Founded2021
Location

190 Passeig de Sant Joan, Barcelona, Catalonia, Spain, 08037

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