Basics Devices

A one-day foundation course for very new recruits, PAs, administrators and support staff in Device Regulatory Affairs and other related areas such as Medical,
Manufacturing, Marketing etc. Suitable for staff in agencies and companies

Who should attend
● The regulatory affairs professional who requires comprehensive information on the subject
● Those professionals who work in functions allied to medical device regulatory affairs such as marketing, medical, Quality, packaging, legal etc.
● Also those working in an administrative capacity alongside medical device regulatory affairs requiring an overview of device regulatory affairs and those returning
to work after a career break.

Course content
The aim of the course is to provide an insight into the regulatory requirements for Medical Devices in the EU. The course will cover
● What is and what is not a medical device
● The European legislation and guidelines concerning medical devices
● The role of the competent authority
● The role of the notified body
● The classification of medical devices
● The “Essential requirements” of a medical device
● The documentation that is required to support a medical device
● The declaration of conformity and the CE mark
● Device labelling
● Clinical evaluation
● Post marketing activities

Our promise
We guarantee you will leave the course with a better understanding of the Device regulatory process and your role within it.