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 under the EU MDR 2017/745 and EU IVDR 2017/746.

 

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.

 


WHAT IS THE IMPACT OF THE NEW MEDICAL TECHNOLOGIES REGULATIONS EU MDR AND EU IVDR IN EUROPE?

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).


TEAM CREDENTIALS


More than 15 years of experience

More than 100 clinical evaluations and studies

More than 500 IVD & medical devices


WHAT IS 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(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

PRODUCT AREAS


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

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.

 


CURATED CLINICAL, REGULATORY AND QUALITY PROJECTS


HOW WE WORK PARTNER TO QUALITY!”

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:


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 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.



    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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