This training provides an overview of the Medical Device Regulation as well as a particular focus on PMS-PMCF processes for medical device manufacturers. The training is delivered by Michael Maier, Senior Partner and Erik Poulsen, Project Associate.
This training provides an overview of the IVDR with a focus on PMS/PMPF for in-vitro diagnostics devices manufacturers. The training is delivered by Dr Rima Padovani and Dr Silvia Anghel, Senior Associates.
Training of internal auditor in relation to country specific requirements within the MDSAP program. This training is provided by Michael Maier, Senior Partner at Medidee.
This training provides the participants with the knowledge to translate the requirements of MDR/IDVR and ISO 13485:2016 in their QMS. Yann Cailler, Senior Associate, delivers this training.
This training provides tools on how to handle cybersecurity with medical devices development.
This training provides an overview of the IVDR for in-vitro diagnostics devices manufacturers. Training description will follow soon. Contact us training[@]medidee.com if you are interested to know more.
This training aims to bring a complete overview of the implementation of the IEC 62304 for the development of software as a medical device. This training is provided by Kim Rochat, Senior Partner at Medidee.
In collaboration with MedicoIndustrien, this course will provide general understanding of EN60601-series, which is the product standard series for electrical medical devices and system. Yannick Charrotton, LHS SA CTO 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.
Three similar programs in Switzerland (Yverdon-Les-Bains and Basel / Muttenz) and Belgium (Louvain-La-Neuve) preparing the future „Person in charge for Regulatory Compliance“ as per Article 15 of MDR/IVDR please follow this link