About this event
Are you an innovative startup in the medical device industry and feel a bit overwhelmed by the Medical Devices Regulation in Europe? Do you more or less understand this Regulation, you are aware of the available guidance documentation, but do not know how and where to start?
This workshop can be the answer to the questions you have on where to start, what to do, and also when to do it. In this workshop, you will learn which steps to take in which order, the key issues to address and pitfalls to avoid.
We will adress the intended purpose of a medical device, the choice of Notified Body, device classification, the use of (harmonized) standards, the Technical Documentation, the Quality Management System, and last but not least the clinical evaluation.
Trainer: Daniëlle Motta
More information: https://briskr.nl/events/10-steps-to-successful-ce-marking-2/