Training

17/03/2022

How to obtain the CE Mark with Medical Devices: Introduction to the EU MDR 2017/745

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 lays 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.

Carmen Martín 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. Carmen 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.

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