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.
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.
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.
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.
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