Gain a latest insight into the European regulatory framework for medical devices focusing on legal basis, technical documentation and clinical evaluation.
Part I of the training covers the European regulatory framework, classification and conformity assessment of medical device.
Part II of the training presents a module-based approach to structuring technical documentation, taking into account the current IMDRF guidance. This approach leverages lessons learned from pharmaceutical regulatory practice to keep pace with the evolution of the global regulatory landscape.
Part III of the training walks you through clinical evaluation requirements. Specifically, the clinical requirements and process for performing clinical evaluation for different categories of software and medical device software are discussed in detail.
The training material is easy-to-follow and based on the new European Medical Device Regulation. After enrollment, all your questions regarding these subjects will be addressed in a timely manner to ensure gain sufficient regulatory knowhow.
Upon completion of this course, you will be able to make good regulatory decisions with confidence and resolve common regulatory issues.