medical device and ivd consulting services

Medical Device & IVD Consulting Services


MDx serves as a reliable ally for MedTech initiatives, delivering an all-encompassing range of services for both medical devices and IVDs. This includes acquiring ISO 13485/ISO 15189 quality certification and developing exhaustive technical documentation compliant with IVDR and MDR regulations. The firm excels in managing clinical studies, a critical step for securing CE marking or FDA approvals. In collaboration with MedTech corporations and their subcontractors, MDx offers a broad array of MedTech consulting services. These services span medical writing, quality assurance, oversight of clinical investigations, clinical performance studies for diagnostics, and comprehensive management of MDR and IVDR clinical evidence requirements.

Medical Device Consulting

Leading the Way in Medical Device Consulting

MDx stands as a trusted partner for enterprises in the MedTech sector, offering a wide-ranging portfolio of services tailored for medical devices. From securing ISO 13485 quality certification to creating rigorous technical documentation in line with MDR regulations, MDx has you covered. The firm’s proficiency extends to clinical studies management, an essential step for obtaining CE marking or FDA approval. Collaborating with industry leaders and their subcontractors, MDx provides specialized medical device consulting services. These encompass medical writing, quality assurance, and clinical investigations management, as well as complete oversight of MDR clinical evidence requirements. Trust MDx for end-to-end solutions that not only ensure compliance but also streamline your journey to market.

Services provided:

  • Clinical Strategy.
  • Study design and protocol development.
  • Clinical document creation and management.
  • Ethics Committee and Competent Authority Submission in the EU.
  • Clinical Investigation monitoring
  • Clinical Investigation Postmarket study design and management.
  • Paper or EDC data collection capability.
  • Clinical database development, entry, processing, querying, maintenance, and reporting.
  • Training for clinical study staff and site-level staff.
  • Creation of study progress reports.
  • Clinical Events Committee/Data Safety Monitoring Board support network.
  • Clinical Quality.


Leaders in IVD Consulting

MDx is your go-to partner in the MedTech arena, offering a full spectrum of services specifically designed for In Vitro Diagnostics (IVDs). From achieving ISO 15189 quality certification to meticulously crafting technical documentation in compliance with IVDR guidelines, MDx provides a one-stop solution. Expertise in managing clinical performance studies is another forte, essential for securing CE marking or FDA approval. In collaboration with IVD companies and their subcontractors, MDx extends specialized IVD consulting services. This range of services includes medical writing, quality assurance, and clinical performance studies management, alongside comprehensive support in navigating IVDR clinical evidence protocols. Count on MDx for all-encompassing solutions that not only meet regulatory benchmarks but also accelerate your market entry.

Technical and Medical Writing:

  • Labeling and Instructions For Use (IFU)
  • General Safety and Performance Requirements (GSPR)
  • Risk Management Plan and Report (RMP and RMR)
  • Clinical Evaluation Plan and Report (CEP and CER)
  • Performance Evaluation Plan and Report (PEP and PER)
  • Post-Market Surveillance Plan (PMSP)
  • Post-Market Clinical Follow Up Plan (PMCFP)
  • Summary of Safety and Clinical Performance (SSCP)
  • Periodic Safety Update Reports (PSUR)

Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.

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MDx | MedTech IVD CRO

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