10 steps to successful CE marking
Are you an innovative startup in the medical device of medtech 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 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. You will learn about 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. After this workshop you will understand what evidence is needed and be able to build up your CE marking strategy.
Bio trainer Danielle Motta
Daniëlle is Head of Global Registrations & Consultant at Qserve Group.
Daniëlle joined the Qserve Group in 2017 and has since supported manufacturers with market access worldwide. She knows what is needed for an effective strategy for CE marking of medical devices which can be lodged to an extend for global registrations. Daniëlle is responsible for the Global Registrations department; a team of regulatory affairs associates and consultants supporting manufacturers with their in-country registrations in APAC, EMEA and LATAM, ensuring effective communication with competent authorities, and designing market access strategies suitable to the manufacturer’s technical documentation available whilst keeping a practical approach. Daniëlle has a MSc. Science, Business and Innovation in Life & Health Sciences.
Specific topics and questions
If you want to participate in this workshop and have specific questions or topics you would like to know more about, do not hesitate to send them to email@example.com. They will be forwarded to the trainer.
We organize this workshop at Noviotech Campus in Nijmegen. There is a free parking lot at Jan Massinkhal at the other side of the street.
Good to know
We finish off by joining the great BBQ from Kadans (Kadans Summer Event). This workshop is free of charge and facilitated in English. We welcome new contacts, so feel free to share this invite with your network! Please register upfront!