Webinars – online training on medical devices
In medical device webinars, we offer live interactive sessions where participants can ask questions and get immediate answers from experts.
1. Introduction to MDR and IVDR: In this basic webinar, we will introduce participants to the new European regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). We will discuss the key requirements, deadlines and steps to comply with the new regulations. The training also includes a discussion of the key changes compared to previous regulations and the impact on manufacturers and suppliers. The webinar is ideal for those who are new to MDR and IVDR and for those who need a quick overview of the key issues. Through an interactive approach, participants will be able to ask questions and get answers to their concerns. Our expert will provide a comprehensive coverage of the topic in a clear and accessible manner.
2. Medical device certification process: A webinar dedicated to the details of the certification process for medical devices according to the MDR. We will discuss the requirements for technical documentation, conformity assessment and the role of notified bodies. The training includes a detailed step-by-step explanation of how to prepare medical devices for the certification process. You will learn what documents are necessary and what tests must be carried out. The webinar is aimed at manufacturers and those responsible for regulatory compliance in companies. Through practical examples and case studies, participants will gain knowledge that will enable them to prepare effectively for the certification process.
3 Risk Management according to MDR: An online training course that focuses on risk management for medical devices. We will examine methods for identifying, assessing and controlling risks as required by the MDR. Participants will learn how to create and update risk management plans and how to document the results of risk analyses. The training also includes a discussion of the tools and techniques used in risk management and the presentation of best practices in the field. Through interactive exercises, participants will be able to apply the knowledge gained in practice on an ongoing basis. The course is designed for quality professionals, engineers and project managers.
4. Clinical evaluation, clinical trials and PMCF: An interactive online training course that discusses the requirements for clinical evaluation and post-market testing of a device. The focus will be on methods for collecting and analysing clinical data and its documentation in accordance with MDR and IVDR. Participants will learn about the requirements for conducting clinical trials and reporting the results to notified bodies. The training also includes a discussion of the principles of good clinical practice (GCP) and the requirements for monitoring and supervising clinical trials. Practical exercises will help participants understand how to prepare and conduct clinical trials in compliance with the regulations. The course is designed for clinicians, research managers and regulatory affairs professionals.
