MDx CRO

medical devices

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.

Technologies

Outlook WordPress.org Vimeo Mobile Friendly Google Tag Manager Apache AI

Keywords

regulatory affairs quality assurance clinical research in vitro diagnostic medical device technical dossier mdr ivdr iso 14155 qms iso 20916 iso 14971 iec 62304 iec 82304 iec 62366 technical documentation ngs cdx infectious diseases compliance iso 13485 iso 9001 performance studies iso 15189 cro gene and cell therapies clinical trial support ivdr performance study toolkit ivdr performance studies assay development services

Location

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

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