medical device and ivd consulting services

Medical Device CRO Services


MDx is your trusted medical device CRO partner, offering comprehensive MD services. Achieve ISO 13485 quality certification and craft robust technical documentation for MDR with MDx expert help. Get a seamless route to CE marking or FDA approval through MDx comprehensive clinical studies management.


The accuracy of the data gathered is critical to the success of the medical device clinical investigations. The clinical affairs team at MDx collaborates with you to ensure that clinical study data is gathered, input, cleaned, and reported in compliance with the protocol and other regulations. The end aim is to offer you high-quality, dependable data for analysis. The clinical affairs team will collaborate closely with you to ensure that the medical device clinical investigation plan accurately represents you to Ethics Committees (EC) and complies with Good Clinical Practice (GCP) guidelines as well as local regulations.

MDx ensures adherence to Good Clinical Practices (GCP), the European Clinical Trial Regulation (No 536/2014), the MDR, and ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects. MDx can be involved in all or part of your clinical operations, depending on your budget and the availability of in-house specialists.

Clinical Investigation Medical Device CRO Services:


Creating detailed technical documentation during the design and development phases of a medical device is a task that demands robust scientific and technical expertise. In the role of a specialized medical device CRO, MDx offers a comprehensive set of services that meet both regulatory obligations and are pivotal for obtaining successful device certifications.

MDx provides exhaustive documentation that covers every facet of the medical device, from design schematics and operating procedures to guidelines for use and clinical evaluations. This also encompasses information on biological assessments and post-market monitoring protocols.

For all categories of medical devices—be it Class I, IIa, IIb, III— a technical file is obligatory. Each technical file compiled by MDx is customized according to the device’s specific class, underlying technology, and associated risk levels. MDx ensures that this critical data is methodically arranged and presented in a manner that facilitates effective scrutiny by Notified Bodies or Competent Authorities, depending on the device’s classification.

With its extensive experience as a medical device CRO, MDx possesses the specialized skills required to prepare technical documentation that not only adheres to all regulatory guidelines but also streamlines the approval process.

Technical and Medical Writing Services:

  • Device Description
  • Labelling and Instructions For Use (IFU)
  • GSPRs
  • Risk Management following ISO 14971
  • Benefit-Risk Ratio
  • Clinical Evaluation Plan and Report
  • Systematic Literature Review Protocol
  • Systematic Literature Review Report
  • Clinical Evaluation Report
  • CER for SaMD/MDSW
  • PMS Plans and Reports (PMSP/R)
  • Periodic Safety Update Reports (PSUR)
  • Post-Market Clinical Follow Up (PMCF)
  • Summary of Safety and Clinical Performance (SSCP)


The landscape of medical devices is increasingly complex, making it vital to engage with a specialized firm in regulatory affairs for medical devices. Partnering with such experts can significantly enhance the efficacy of compliance initiatives. MDx serves as this expert entity, proficient in aiding companies to fulfill all regulatory demands. Whether the focus is on establishing the grounds for device equivalence, validating a regulatory pathway, crafting a clinical evaluation strategy, or facilitating market approvals, MDx provides invaluable regulatory guidance.

MDx brings to the table a wealth of expertise in regulatory affairs, supporting medical device manufacturers of varying sizes in navigating the complexities of European market entry. With its comprehensive background as a medical device CRO, MDx offers targeted solutions that not only ensure regulatory compliance but also expedite the market approval process.

Regulatory Affairs with Medical Device Manufacturers:

  • Device classification
  • Regulatory strategy
  • Regulatory roadmaps
  • Technical documentation gap assessments
  • EU MDR Remediation
  • EU MDR Implementation
  • EU MDR PMS implementation
  • Clinical evidence assessment
  • ISO 62304
  • Economic Operators
  • UDI consulting
  • EU MDR Consultation processes (CECP and EMA)


MDx is a recognized leader in the Medical Device consulting space, with specialized focus on MDR Quality Assurance and Quality Management Systems (QMS).

The firm identifies client-specific QMS needs and collaborates to develop, implement, and maintain these systems. With a history of successfully aiding numerous clients in managing their QMS, MDx prepares key stakeholders, such as manufacturers, for audits conducted by Notified Bodies and other certification organizations. For a thorough understanding of MDx’s capabilities in quality assurance for medical devices, further inquiry is advised.

Medical Device Quality Assurance Services:

  • QMS development, implementation and management.
  • QMS gap assessment & transition
  • ISO 13485
  • ISO 9001
  • ISO/IEC 17025
  • 21 CFR Part 820
  • Remote and onsite Auditing
  • QA and RA due diligence audits
  • Quality assurance outsourcing
  • Interim Management
  • Spreadsheet Validation


Seeking support for the approval and registration of medical devices?

MDx offers specialized consulting services in medical device approvals, catering to both European and U.S. markets. With a team of experts well-versed in CE Mark and FDA processes, MDx leverages its network within the MedTech ecosystem to expedite registration procedures. The aim is to secure medical device approval as efficiently as possible for clients.

Approval and registration services:

  • CE Mark submissions
  • Strategic review of technical documentation structure
  • Notified Body and NCA response resolution
  • Completion of Notified Body application forms
  • Manufacturer and Importer license
  • Local device registration
  • Notified Body Communication
  • National Competent Authorities Communication
  • EUDAMED registration


MDx serves as a vital training partner in the MD consulting landscape. The firm’s experts integrate seamlessly with manufacturing teams to provide specialized training. This guidance focuses on the strategic design, coordination, and development of clinical and scientific documentation, all aimed at achieving competitive timeframes for project completion.

Medical Device Trainings:

  • EU MDR 2017/746
  • ISO 13485
  • ISO 14971 Application of risk management
  • ISO 14155 Clinical Investigation studies for human subject medical device

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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