The Quality, Regulatory and CRO partner in the MedTech IVD sector
Your CE Marking-FDA Medical Device CRO strategist
Working with you from the MedTech Patent to the Post-market
A MedTech CRO is a company that provides contract research organization services to aid medical device manufacturers in the entire process, from patent to post-market support. By offering expert consulting, quality assurance, medical device regulatory affairs, and clinical investigation expertise, it serves as the optimal partner for the development of medical technologies.
An IVD CRO is a contract research organization that specializes in supporting IVD manufacturers and laboratories from the In-Vitro Diagnostics patent to the post-market phase. Through providing expert consulting in quality assurance, regulatory compliance, and clinical performance, the IVD CRO establishes itself as the ideal partner for the advancement of in-vitro diagnostics technologies and in-house testing capabilities.
As a Medical Device CRO in Europe, MDx offers complete life-cycle expert support for your medical device and in-vitro diagnostic projects. The expert team designs an optimal plan for your CE Mark strategy to save time and resources in your medical device and IVD innovation pipeline. Covering the quality support in your QMS, the regulatory affairs consulting services for the development of Technical Documentation, and the medical writing for Clinical Evaluation and IVD Performance Evaluation and the Clinical Research Operations management under the EU MDR 2017/745 and EU IVDR 2017/746.
Quality Assurance consulting services provide design, implementation, and management of Quality Management Systems following several standards for healthcare companies.
Medical device regulatory affairs consulting services cover the intended purpose definition of technical file development and other key points such as Risk Management and Clinical Evaluation.
The Clinical Research expert and strategist support provide the design and development of clinical investigations and performance studies. Medical Device Contract Research Organization services dedicated for Medical Devices, IVD and MDSW.
The EU Medical Device Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Regulation (IVDR) 2017/746 came into effect on May 26, 2021 and 2022, respectively. These new European regulations bring significant changes for MedTech manufacturers, including expanded product coverage, alignment with European and international regulations, reclassification based on risk, stricter clinical evidence requirements, heightened scrutiny and involvement of Notified Bodies, increased focus on post-market surveillance, and updated quality management system (QMS) requirements for medical devices and in vitro diagnostics manufacturers.
More than 15 years of experience
More than 100 clinical evaluations and studies
More than 500 IVD & medical devices
IVD Contract Research Organization
From the manufacturing (ISO 13485) and laboratory (ISO 15189) Quality Management System Implementation, IVDD to IVDR regulation transition, Performance Evaluation and the design and the implement of the Clinical Performance Studies (observational and interventional), MDx IVD CRO offers support for in-vitro diagnostics devices, in-house IVDs and LDTs (laboratory developed tests).
Medical Device Contract Research Organization
The medical device CRO and the regulatory consultant partner to develop the complete Medical Device CE Marking.
With solid services in Quality Management System Implementation, MDD to MDR regulation transition, Clinical Evaluation and the design and the implement of the Clinical Investigations, PMCF studies and RWE/RWD.
SaMD Contract Research Organization
Collaboration with a healthcare software developer to get the CE Mark for Digital Health Solutions. Beginning with the implementation of dedicated Quality Management Systems for the design and development of SaMD (ISO 13485) and cybersecurity (ISO 27001), Data Science, Validation and Verification (ISO 62304), and Software Clinical Evaluations, which are supported by Clinical Evidences.
IVD CRO services for the development of a Clinical Performance Study for an IVD kit according ISO 20916:2019, GLP, GCP and EU IVDR 2017/746.
Development of the full MDR transition, including the Clinical Evaluation Plan, Systematic Literature Protocol and Report and the Clinical Evaluation Report according MEDDEV 2.7.1 rev 4, MDCG 2020-6 and EU Medical Device Regulation 2017/745
Medical Device CRO services for the development of a Clinical Investigation for an MDSW according ISO 14155:2020, MDCG 2020-10 rev.1, MDCG 2021-6, MDCG 2021-8, MDCG 2021-20, MDCG 2021-28 and EU MDR Regulation 2017/745 in one Spanish site.
Local Medical Device CRO activities in one Spanish site from Ethics Committee submission to the Close Out according ISO 14155:2020 and EU MDR Regulation 2017/745.
Local Medical Device CRO activities in five Spanish site from site management to the Close Out, according GCPs and ISO 14155:2020.
Quality Assurance Service support: Quality Management System ISO 13485 development and implementation.
Quality Assurance Service support: Quality Management System ISO 13485 development, implementation and maintenance.
Quality Assurance Service support: External Audits
MDx offers comprehensive consulting and project management services to help you achieve success in the competitive MedTech landscape.
MDx expertise in Medical Device Regulation, In-Vitro Diagnostic Regulation, ISO 14155, and ISO 20916 ensures that your projects are completed in compliance with industry standards.
Even when MDx adapts the project management for each MedTech manufacturer or Medtech CRO project, MDx provides some common steps and processes to facilitate transparency and control, using the following steps:
A strategist expert will collaborate with you to land the project defining activities and timelines. An easy-to-read budget will be released.
Both teams, manufacturer and MDx CRO, are introduced. The initial setup is established with the project's plan, milestones, and timelines.
MDx team will provide periodic updates and ad-hoc meetings to cover the project´s needs.
The documentation will be shared with the manufacturer. The documentation is assessed by the manufacturer, and after that, the final version is released.
The last contact to evaluate the results of the project takes place with the team. It is the stage for exploring new projects.
What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? Continue reading. The In Vitro Diagnostic Regulation (IVDR) is a new regulation that took effect on May 26, 2022, replacing the In Vitro Diagnostic Directive (IVDD) and introducing new requirements for manufacturers of in vitro diagnostic medical devices... read more
Learn more about the MedTech news from the latest IVD trends to the main figures in medical technology.
In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of Regulation (EU) 2023/607, which amends transitional provisions for specific medical devices and in vitro diagnostic devices under Regulations (EU) 2017/745 and (EU) 2017/746. The EU Q&A document provides further clarity to the MDR/IVDR amendment, which... read more
What are some of the most important things you’ll need to know for IVD clinical trials in 2023? Continue reading to learn more. In-vitro diagnostics (IVD) are tests performed on biological samples, such as blood or tissue, to diagnose or monitor medical conditions. IVD devices are coming out with new and improved features leading to... read more
The Medical Device Regulation (EU MDR) has introduced significant changes to the requirements for clinical evaluation of medical devices. This article will provide a comprehensive guide on incorporating the most relevant guidance from MDCG 2020-6, MDCG 2020-5, MDCG 2020-13, MEDDEV 2.7.1 rev4, and EU MDR Annex XIV into your MDR Clinical Evaluation Report (CER).
We are delighted to meet with you for a free initial consultation to provide expert support and learn more about your project, medical device, software as a medical device or IVD under IVDR and MDR regulations.
Please provide a brief description of your project, and we will work to establish the next steps in your regulatory, clinical research (clinical trials, clinical investigations and clinical performance studies) and quality strategic planning.
Contact us today to learn more about our MDx services and how we can help you achieve your goals in the fast-evolving of the medical technologies as your medical device CRO/ IVD CRO partner.
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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