Your Full Service MedTech IVD CRO partner
MDx is your One Stop-Shop CRO for Medical Devices and IVDs
Working with you from the MedTech Patent to the Post-market
WHAT IS A MEDTECH CRO?
A MedTech CRO is a company that provides contract research organization services to aid medical device (MD) manufacturers. It covers the MD full life cycle. By offering expert consulting, quality assurance, medical device regulatory affairs, and clinical investigation expertise, it serves as the strong partner for the development of medical technologies.
WHAT IS AN IVD CRO?
An IVD CRO is a specialized contract research organization. It supports In Vitro Diagnostics (IVD) manufacturers and laboratories from patent to the post-market phase. An IVD CRO provides quality assurance, regulatory and clinical performance expertise to be the optimal partner for the development of in-vitro diagnostics technologies and in-house testing.
MDx, YOUR MEDTECH IVD CRO
As a MedTech IVD CRO in Europe, MDx offers complete life-cycle expert support for your medical device and in-vitro diagnostics projects. The expert team designs an optimal plan for your CE Mark strategy to save time and resources in your medical device and diagnostics 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.
MEDICAL AND DIAGNOSTICS CRO SERVICES
MDx CRO offers an integrated approach to managing the complete lifecycle of medical products. Specializing in MedTech CRO services, MDx provides expertise in research and development, clinical research, regulatory processes, and post-market activities. MDx simplifies the complex steps needed to bring a medical product to market, ensuring a streamlined, efficient process that meets industry standards. MDx offers the holistic solution in medical technology development.
Quality Assurance consulting services provide design, implementation, and management of Quality Management Systems following several standards for healthcare companies.
MedTech 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 IMPACT OF EU MDR AND EU IVDR ON THE ADOPTION OF MEDICAL TECHNOLOGY IN EUROPE
New EU regulations came into effect for MedTech and IVD companies. 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. Namely, these new European regulations bring significant changes for MedTech IVD. Among the most relevant are 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.
TEAM CREDENTIALS
MDx stands at the forefront of the MedTech and In Vitro Diagnostics industries, offering unparalleled expertise and innovative solutions. Our seasoned MDx experts guide clients through every step of product development, clinical studies, and regulatory compliance. With a commitment to quality and cutting-edge technologies, we transform challenges into strategic advantages, setting a high benchmark in MedTech CRO and IVD CRO services. Partner with us to navigate the complexities of the rapidly evolving MedTech landscape with confidence.
Over 17 years of experience
More than 100 clinical evaluations and studies
Worked with 500 IVD & medical devices
THE DIFFERENCE BETWEEN CLINICAL TRIALS, CLINICAL INVESTIGATIONS AND CLINICAL PERFORMANCE STUDIES
- EU MDR 2017/745 defines clinical investigation as a systematic study involving human subjects to evaluate the safety or performance of a medical device;
- EU IVDR 2017/746 defines clinical performance study as a study done to establish or confirm the clinical performance of a device, which is the ability of a device to produce results that are related to a particular clinical condition, physiological or pathological process or state, and the target population and intended user;
- ICH E6 defines clinical trial as an investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.
MEDTECH CRO PRODUCT AREAS
IVD Contract Research Organization
Specializing in ISO 13485 manufacturing and ISO 15189 laboratory Quality Management Systems, MDx serves as a valuable resource for organizations navigating the transition from IVDD to IVDR regulations. The company excels in carrying out comprehensive Performance Evaluations and in the design and implementation of Clinical Performance Studies, both observational and interventional. As a leading IVD CRO, the organization also offers specialized support for in-house IVDs and LDTs (Laboratory Developed Tests).
Medical Device Contract Research Organization
As a reputable MedTech CRO, MDx collaborates with regulatory consultants to provide comprehensive solutions for Medical Device CE Marking. Excelling in Quality Management System Implementation and adept at guiding transitions from MDD to MDR regulations, the company is a leader in the field. The Medtech CRO further distinguishes itself through its expertise in Clinical Evaluation, as well as in the design and execution of Clinical Investigations, PMCF studies, and Real-World Evidence/Real-World Data collection.
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.
CURATED CLINICAL, REGULATORY AND QUALITY PROJECT EXPERIENCE
Asian Manufacturer
Clinical Performance Study | IVD Multiplex Respiratory Virus
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.
European Dental Manufacturer
Clinical Evaluation Report (MDD to MDR) | Dental Products
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.
Spanish Manufacturer
Clinical Investigation Pre-Market | Medical Device Software (MDSW)
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.
ENT Australian Manufacturer
Clinical Investigation Pre-Market | Medical Device Class III implantable
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.
Cardiovascular Canadian Manufacturer
Clinical Investigation Post Market | Medical Device Class IIa
Local MedTech CRO activities in five Spanish site from site management to the Close Out, according GCPs and ISO 14155:2020.
IVD Spanish Manufacturer Start-up
QMS ISO 13481
Quality Assurance Service support: Quality Management System ISO 13485 development and implementation.
IVD Spanish Manufacturer Medium size
QMS ISO 13485
Quality Assurance Service support: Quality Management System ISO 13485 development, implementation and maintenance.
Medical Device Spanish Manufacturer Medium size
QMS ISO 13485 Audits
Quality Assurance Service support: External Audits
HOW WE WORK PARTNER TO QUALITY!”
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 or IVD CRO project, MDx provides some common steps and processes to facilitate transparency and control, using the following steps:
Step 1. First Consultation
A strategist expert will collaborate with you to land the project defining activities and timelines. An easy-to-read budget will be released.
Step 2. Kick-off Meeting
Both teams, manufacturer and MDx CRO, are introduced. The initial setup is established with the project's plan, milestones, and timelines.
Step 3. Project Development
MedTech CRO MDx team will provide periodic updates and ad-hoc meetings to cover the project´s needs.
Step 4. Project Delivery
The documentation will be shared with the manufacturer. The documentation is assessed by the manufacturer, and after that, the final version is released.
Step 5. Service Assessment
The last contact to evaluate the results of the project takes place with the team. It is the stage for exploring new projects.
FDA Laboratory Developed Tests (LDTs) Regulation
IVD news
The Food and Drug Administration (FDA) recently released a groundbreaking proposed rule on September 29, 2023, aiming to transform its existing approach toward Laboratory-Developed Tests (LDTs). This paradigm shift directly impacts In Vitro Diagnostic products (IVDs) and their regulation.
Learn more about the MedTech news from the latest IVD trends to the main figures in medical technology.
EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions
MEDTECH news
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.
MDR Clinical Evaluation Report: The Roles of MEDDEV and MDCG Explained
MEDTECH news
The EU Medical Device Regulation has introduced significant changes to the requirements for clinical evaluation reports of medical devices. This article provides a guidance on incorporating the relevant guidance from MDCG 2020-6, MDCG 2020-5, MDCG 2020-13, MEDDEV 2.7.1 rev4, and EU MDR Annex XIV into your CER.
Companion diagnostic studies: BSI & TÜV SÜD Lead the Way in CDx Certification
IVD news
The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies in the European Union, have issued their first Companion Diagnostic (CDx) Certificates under the In Vitro Diagnostics Regulation (IVDR). This achievement carries substantial implications for IVD manufacturers and CROs.
REQUEST YOUR EXPERT CONSULTATION
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 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 MedTech CRO and 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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