Open classroom training courses offer direct interaction with the trainer and other participants, which promotes the exchange of experiences and the deepening of knowledge. These training courses are conducted on site, allowing a more practical approach to the topics discussed, often using examples and case studies.
1. Technical documentation of medical devices: A practical training course that focuses on creating and maintaining technical documentation in accordance with MDR and IVDR requirements. We will discuss what documents are required, how to prepare them and how to manage changes to the documentation. Participants will learn how to create and update technical documentation. The training also includes a discussion of incident reporting and corrective action requirements and how to effectively manage documentation in a quality management system. Practical examples and exercises will help participants understand how to meet regulatory requirements for technical documentation. The course is designed for engineers, project managers and regulatory professionals.
