MDF11 Introduction to Medical Devices

Description

To give attendees an overview of what is a medical device, the classification rules, regulatory landscape (focusing primarily in the European Union), and the main documents that medical writers are involved with. The workshop will also explore the role of the medical writer, the necessary skills and possible challenges to overcome when working in the medical devices area.

Participant profile: new/aspiring medical writers who are interested in writing for medical devices, or experienced medical writers, who usually work in medical communications or in regulatory (drug development) and want to learn about medical devices. This is an introductory workshop, so the only ones who will not benefit from it are those who already work in medical devices and have an understanding of the processes and documents involved.