This training provides the participants with the knowledge and basic skills required to plan, launch and control a Usability project. Kim Rochat, Senior Partner, delivers this training
Understanding CE-Marking and correlation between standards referenced in IEC 60601- series. Ralf Gasser shares his +20 years testing expertise and proposes solutions. English training
From RA impact on embedded or standalone SW to design, controls and setup of documentation. Covers 62304 QMS implementation. Kim Rochat, Senior Partner, delivers this training.
Intensive day on organization & methods, execution in role plays & keys of supplier audits. Prepares for ISO 9001, 13485, 17025. E. Lovejoy & C. Fattebert, Senior Associates deliver this training.
Join us in Brussels for one day on medical devices. A unique opportunity to approach the Belgian MedTech ecosystem, its challenges and stakeholders. Learn from experts & latest innovations. Connect with partners
Half day training covering the MDR/IVDR Requirements regarding IFU, e-IFU, labelling for Medical Devices and IVD’s. You’ll also get to know how and when to implement UDI. This training is delivered by Yann Cailler, Senior Associate.
Half day training for an introduction to the new Regulation, overview of Technical Documentation Requirements and Performance Evaluation for IVD’s. Dr. Rima Padovani provides this training.