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
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
TESTIMONIALS
HealthCare Manager at Philips
Javier Martín
It has been a pleasure to work with David, supporting our devices with evidence-based science. Your timely support was key for the devices.
Investigator and Scientific Adviser for medical devices
Pepe Amengual
An excellent collaboration for our clinical evaluation. I appreciate your professionalism and fluent communication. Thank you!
Regulatory Affairs and Design Quality Director at Biokit, A Werfen Company
Àngels Roma
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.
Director of Biotechnology at CNIO
Fernando Pelaez
Highly knowledgeable, efficient, and resolutive. A great partner to address issues related to quality assurance and regulatory processes
Head of Clinical Affairs at Overture Life
Beatriz Maroto
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.
Clinical Research Programme Managing Director at CNIO
Antonio López
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!
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
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.
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 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!
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.
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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