medical device and ivd consulting services

IVD CRO Services


A specialized In Vitro Diagnostics CRO is essential in the lifecycle of IVD technologies and products. MDx guides IVD manufacturers and laboratories from the patent phase to post-market activities, focusing on quality assurance, regulatory compliance, and clinical performance. This establishes MDx as a reliable partner in the development and in-house testing of in-vitro diagnostic services.


MDx, a leading In Vitro Diagnostics CRO in Europe, provides comprehensive support throughout the lifecycle of in-vitro diagnostics technologies. The company offers assistance in Quality Management Systems (QMS), regulatory affairs consultancy for Technical Documentation development, and medical writing expertise for IVD Performance Evaluation. MDx’s management of Clinical Operations is aligned with the EU IVDR 2017/746 regulation and FDA approval, ensuring that projects meet the highest standards.

  • Your go-to partner for cutting-edge IVD development and clinical performance IVD CRO services.
  • Specialists in quality assurance, regulatory compliance, and clinical performance, guiding you from patent to post-market.
  • Tailored solutions for startups to global IVD manufacturers and their pharma partners.
  • Exceptional customer service and quality, ensuring every project meets the industry’s highest standards.
  • ISO 9001 Accredited IVD CRO
  • Access to an extensive network including Notified Bodies (NBs), EU Commission, IVD trade associations, global clinical sites, and more…


Data accuracy is pivotal for the success of In Vitro Diagnostic (IVD) clinical performance studies. MDx’s clinical affairs team works in tandem with you to guarantee the quality and compliance of collected clinical data, adhering to the clinical performance study plan and other relevant regulations. The ultimate goal is to provide you with reliable, high-grade data for subsequent analysis. The team collaborates closely with you to ensure that the IVD clinical study plan not only meets but also exceeds the expectations of Ethics Committees (EC), adhering to Good Clinical Practice (GCP) guidelines as well as local and international regulations.

MDx ensures strict compliance with Good Clinical Practices (GCP), the EU IVDR 2017/746, and ISO 20916:2019 In vitro Diagnostic Medical Devices – Clinical Performance Studies using specimens for human subjects – Good study practice.

Clinical Performance IVD CRO Services:

  • Clinical Strategy
  • Strategic feasibility
  • Laboratories selection and qualification
  • Study design and protocol development
  • Ethics Committee Communications and submissions
  • National Competent Authorities Communications and submissions
  • Clinical Performance study monitoring
  • Data Source Verification for sites and laboratories
  • Creation of study progress reports
  • Data Management
  • Biostatistics
  • Clinical Performance Study Report
  • eCRF data collection capabilities
  • eTMF
  • Electronic CTMS
  • Importation assistance of IVDs for performance Studies
  • Clinical Performance Study Sponsor´s legal representative art 58
  • ISO 20916 assessments


Developing comprehensive technical documentation throughout the design and development stages of an In Vitro Diagnostic (IVD) device requires a deep understanding of both scientific and regulatory nuances. As a specialized IVD CRO, MDx offers a complete range of services aimed at fulfilling regulatory requirements critical for successful device certification.

MDx produces thorough documentation that spans all aspects of the IVD device, from design file and operational protocols to usage guidelines and performance evaluations. This also includes details on analytical testing and post-market surveillance plans.

For every classification of IVD devices—be it Class A, B, C, or D—a technical file is mandatory. MDx tailors each technical file to match the device’s unique classification, technology, and risk management. The company ensures that this vital data is meticulously organized and presented in a format conducive for efficient evaluation by Notified Bodies or Competent Authorities, depending on the device’s classification.

Leveraging extensive experience as an IVD CRO, MDx has the specialized skill set to craft technical documentation that not only complies with all regulatory guidelines but also expedites the approval process.

Technical and Medical Writing Services:

  • Medical writing services
  • Labelling and Instructions For Use (IFU)
  • GSPRs
  • Risk Management documentation
  • Performance Evaluation Plan and Report (PEP and PER)
  • Analytical Performance Report (APR)
  • Scientific Validity Report (SVR)
  • PMS Plans and Reports (PMSP/R)
  • Periodic Safety Update Reports (PSUR)
  • Post-Market Performance Follow Up(PMPF)
  • Summary of Safety and Performance (SSP)
  • CLSI documentation development
  • WHO pre-qualification


Navigating the intricate landscape of In Vitro Diagnostics necessitates the expertise of a specialized IVD CRO in regulatory affairs. Partnering with such a specialized entity can substantially improve the effectiveness of compliance efforts. MDx serves as this specialized consultant, well-versed in helping companies meet all regulatory criteria. Whether the goal is to establish the basis for diagnostic equivalence, validate a specific regulatory path, devise a clinical evaluation strategy, or secure market approvals, MDx offers crucial regulatory guidance.

MDx possesses extensive experience in regulatory affairs, aiding IVD manufacturers of all sizes in overcoming the complexities associated with entering the European market. Drawing upon its comprehensive background as an IVD CRO, MDx provides targeted solutions that not only fulfill regulatory requirements but also accelerate the market approval process.

Regulatory Affairs for IVD Manufacturers:

  • Device classification
  • Regulatory strategy and roadmaps
  • Technical documentation development
  • EU IVDR Implementation
  • EU IVDR PMS implementation
  • IVD Clinical evidence assessment
  • Economic Operators
  • UDI consulting
  • Technical documentation gap assessments
  • ISO 14971 documentation development
  • EU IVDR Consultation processes (PECP and EMA)


MDx stands as a recognized authority in the In Vitro Diagnostics (IVD) consulting sector, with a specialized emphasis on IVDR Quality Assurance and Quality Management Systems (QMS).

The firm assesses the unique QMS requirements of each client and collaboratively develops, launches, and maintains these systems. With a track record of successfully assisting multiple clients in the management of their QMS, MDx IVD CRO readies key stakeholders—such as diagnostic manufacturers—for audits carried out by Notified Bodies and other accreditation agencies. For a comprehensive overview of MDx’s expertise in quality assurance for IVDs, additional consultation is recommended.

IVD CRO Quality Assurance Services:

  • QMS development, implementation, administration and management.
  • QMS gap assessment & transition
  • ISO 13485
  • ISO 9001
  • ISO 15189
  • 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 IVD 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
  • Mock Notified Body CE assessments
  • Completion of Notified Body application forms
  • Manufacturer and Importer license
  • Local device registration
  • Notified Body and NCA communication
  • EUDAMED registration


MDx functions as an indispensable training ally in the In Vitro Diagnostics CRO sector. The company’s seasoned professionals collaborate closely with manufacturing units, offering targeted training. This instruction is centered around the calculated planning, organization, and creation of scientific and clinical documents, all with the goal of meeting ambitious project timelines.

IVD Trainings:

  • EU IVDR 2017/746
  • ISO 13485
  • ISO 14971 Application of Risk Management
  • ISO 15189 QMS for Clinical Laboratories
  • ISO 20916 IVD medical devices-Clinical performance studies for human subjects
  • Training on Notified Body expectations

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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