The largest network of innovation research groups in Catalonia led by CREB UPC is organizing a series of formations for all the members of its community that will take place every Thursday morning throughout the year. These trainings are classified into three basic blocks, namely, a block on valorization, a block on technology transfer and a block on soft skills.
Xartec Salut’s third formative session was led by Carmen Martín, Regulatory, Quality and Clinical Afffairs SME Consultant. The expert provided an overview on the main “Opportunities, Challenges and Tips for Funding Innovation in the Health Sector“.
Medical technologies are the top technical field in patent applications in Europe since 2020. However, only a small percentage of these patents obtain the CE Mark, which is one of the most important milestones. European certification requires meticulous planning by the manufacturer from a regulatory perspective.
In order to ensure that medical devices are safe, this training laid the foundation for regulatory planning, beginning with the classification of the device, the EU regulatory ecosystem, the conformity assessment procedure, the clinical evaluation, the development of the technical documentation, and the requirements for quality management system certification and registration.
Martin has a career of more than 25 years of experience in Regulatory Affairs, Clinical Research and Quality Assurance, working with the Medical Devices Industry. Carmen is an expert in ensuring that regulatory strategies are conducted effectively to meet business objectives and legal requirements as well as protect life and human health. She has led over 200 internal and external audits as a lead auditor and technical product specialist for Medical Devices and In-Vitro Diagnostic devices as well as their manufacturers. Carmen is also a MedTech guest speaker in the start-up and university ecosystem. Know more about her here.
This project is co-funded by the European Union through the European Regional Development Fund (FEDER, Fondo Europeo de Desarrollo Regional).