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
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.
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.
More than 20 years of experience
More than 200 internal and external audits
More than 500 IVD & medical devices
It has been a pleasure to work with David, supporting our devices with evidence-based science. Your timely support was key for the devices.
An excellent collaboration for our clinical evaluation. I appreciate your professionalism and fluent communication. Thank you!
Carmen is an extraordinary professional with a bast knowledge in IVD Regulations. She has been diligent about collecting information and providing complete reports, which have been very helpful in achieving our project milestones. Most importantly to us, Carmen always indicates the practical applications her work has for our organization.
Highly knowledgeable, efficient, and resolutive. A great partner to address issues related to quality assurance and regulatory processes
I have had the opportunity to collaborate with Carmen in different areas of the regulatory universe, and she has always been essential in the success of the projects we have worked on together. Carmen is an extraordinary professional, hard worker, efficient partner, and always provides alternatives and solutions coming from her extensive experience and knowledge. She is a referent in the regulatory and quality assurance field, and it is always a great experience to work with her.
Accurate and professional service. Carmen has the knowledge we need for implementing quality assurance on the basic, pre-clinical and clinical protocols to ensure compliance with the regulatory requirements!
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:
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 Med-IVD Tech, are introduced. The initial setup is established with the project's plan, milestones, and timelines.
Med-IVD Tech 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, 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.
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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