WHAT IS A MEDTECH CRO?

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.

 

WHAT IS AN IVD CRO?

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 IS THE MEDTECH-IVD CRO

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.

 

SERVICES



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.

 


TEAM CREDENTIALS


More than 15 years of experience

More than 100 clinical evaluations and studies

More than 500 IVD & medical devices


PRODUCT AREAS


IVDR
In Vitro Diagnostic
MDR
Medical Device
SaMD / MDSW
Digital Health

In Vitro Diagnostic Contract Research Organization

From the manufacturing (ISO 13485) and laboratory (ISO 15189) Quality Management System  Implementation, IVDD to IVDR transition, Performance Evaluation and the design and the implement of the Clinical Performance Studies (observationals and interventionals), IVD in-house support.

Medical Device 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 transition, Clinical Evaluation and the design and the implement of the Clinical Investigations, PMCF studies and RWE/RWD.

Software as a Medical Device 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 PROJECTS


HOW WE WORK PARTNER TO QUALITY!”

MTD offers well-structured consulting project management to achieve success with you.

Even when MTD 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:


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 MDT, are introduced. The initial setup is established with the project's plan, milestones, and timelines.

Step 3. Project Development

MDT 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.


Companion Diagnostic in Precision Medicine

IVD NEWS

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.

Companion Diagnostic in Precision Medicine

Learn more about the MedTech news from the latest IVD trends to the main figures in medical technology.

AI and the Software as a Medical Device

SOFTWARE MD/IVD NEWS

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.

AI and the Software as a Medical Device

How Many new medical devices are developed per year?

MEDTECH NEWS

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!

How Many new medical devices are developed per year?

How many MedTech companies are there in Europe?

MEDTECH NEWS

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!

How many MedTech companies are there in Europe?

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.

Please provide a brief description of your project, and we will work to establish the next steps in your regulatory, clinical and quality strategic planning.



    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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