The Quality, Regulatory and CRO partner in the MedTech-IVD sector
Your CE Mark-FDA strategists for medical devices
Working with you from the Patent to the Post-market
A MedTech CRO is a contract research organization that specializes in supporting Medical Device manufacturers from the medical device patent to the post-market. A MedTech CRO provides quality assurance, regulatory and clinical investigation expertise to be 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. An IVD CRO provides quality assurance and regulatory and clinical performance expertise to be the optimal partner for the development of in-vitro diagnostics technologies and in-house testing.
MDT 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 Technical Documentation development, the Clinical Evaluation writing 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.
The 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. Contract Research Organization Services dedicated for Medical Technology, IVD and MDSW.
EU MDR 2017/745 and EU IVDR 2017/746 entered into force on May 26, 2021 and 2022, respectively. For the MedTech manufacturers, the new European regulations represent an expansion of the scope to include more products, a global convergence of other European and international regulations, a risk-based reclassification, stricter clinical evidence requirements, increased scrutiny and involvement of Notified Bodies, a greater emphasis on Post-market surveillance, and new requirements for the medical devices and in vitro diagnostics manufacturers’ quality management systems (QMS).
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 (observationals and interventionals), IVD in-house support.
MD Contract Research Organization
Partnering with MedTech manufacturers 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.
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
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.
MDT offers well-structured consulting project management to achieve success with you.
MDT´s SOPs complies with the Medical Device Regulation, In-Vitro Diagnostic Regulation, ISO 14155 and ISO 20916.
Even when MDT adapts the project management for each MedTech manufacturer´s project, device, and need, MTD 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 MDT, are introduced. The initial setup is established with the project's plan, milestones, and timelines.
MDT 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.
65% of EMA and FDA drug approvals involved a biomarker between 2015 and 2019. Currently, 44 CDx are approved by the FDA, and the most relevant categories in terms of the number of approvals are NSCLC and colorectal cancer.
Learn more about the MedTech news from the latest IVD trends to the main figures in medical technology.
Deep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.
The European Patent Office (EPO) received over new 14,200 medical technology patent applications in 2020, a 2.6% increase from the previous year. MedTech is the Top 1 technical field in patent applications. Congratulations!
Over 32,000 medical technology companies exist, 95% of which are SMEs. Our sector employs over 730,000 in Europe. It is an honor to be part of this exciting industry!
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.
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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