10 steps to successful CE marking (+BBQ)
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. 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.
Bio trainer Peter Reijntjes
Peter is Principal consultant Quality & Regulatory Affairs and Head of Training within the Qserve Group.
After an extensive career at KEMA Quality (nowadays known as DEKRA Certification) Peter joined the Qserve Group in 2007 to combine his quality system knowledge with the regulations in the medical device industry.Peter uses a pragmatic and practical approach with a strong focus on strategic and operational compliance and excellence. He is well known for his trainings.
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 in a live setting at Novio Tech Campus in Nijmegen and will take all necessary RIVM/national measures into account. If a physical workshop is not possible, we will reschedule to a later date or convert to online.
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!
A few days before the event we will send an email from firstname.lastname@example.org with practical information on directions/parking etc.