MEDICAL DEVICE & IVD CONSULTING FIRM

Med-IVD Tech is the expert consulting firm for Regulatory Affairs, Clinical Research, and Quality Assurance for the MedTech and IVD industries. Med-IVD Tech 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 and FDA strategy to save time and resources in your medical device innovation pipeline.

 

SERVICES

The Regulatory Affairs consulting services cover from the intended purpose definition to technical file development and other key points such as the Risk Management and the Clinical Evaluation. The Clinical Research expert and strategist support provide the design and development of clinical investigations and performance studies. The Quality Assurance consulting services provide design, implementation, and management of the Quality Management Systems following several standards for healthcare companies.



Med-IVD Tech is the expert consultant to the MedTech Industry.

Its team of regulatory strategists aims to save time and resources in launching your MedTech innovations in Europe and the United States.

More than 20 years of experience working with medical technologies, with extensive knowledge of the MedTech regulations and their stakeholders.

Expertise, scientific background, and a systematic approach to support manufacturers, start-ups, and established companies in their projects.

Med-IVD Tech collaborates with the MedTech Startup ecosystem, sharing its integrated know-how to reach the market in a timely manner.

Please check out the members of our experienced team and testimonials from our clients.


TEAM CREDENTIALS


More than 20 years of experience

More than 200 internal and external audits

More than 500 IVD & medical devices


PRODUCT AREAS


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

TESTIMONIALS


HOW WE WORK PARTNER TO QUALITY!”

Med-IVD Tech offers well-structured consulting project management to achieve success with you.

Even when Med-IVD Tech adapts the project management for each MedTech manufacturer´s project, device, and need, Med-IVD Tech 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 Med-IVD Tech, are introduced. The initial setup is established with the project's plan, milestones, and timelines.

Step 3. Project Development

Med-IVD Tech 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, 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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    Med-IVD Tech | QA RA & CRO

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