Medical Device Industrialization

Description

Intellectual Property (Jean-Paul Maujean, 8h) Introduction to awareness of intangible rights and the concept of e-reputation. Elements of literary and artistic property law and application of these rights in the industrial field. Patents and trademarks; protection of designs and models. Competition law and intellectual property. Medical Device Industrialization (52h) The medical device field is the most stringent from a regulatory perspective and requires thorough knowledge of regulations. The objective of this module is to quickly make students operational in design, methods/industrialization, or quality/regulatory positions. Students will become familiar with essential tools (risk management, sampling justification using valid statistical methods, use of technical standards). The teachings in this module are a strong added value for junior ENSMM engineers in the demanding and regulated medical device field. They will be conducted as follows: • Medical device industrialization: Presentation of quality/regulatory framework. • Design transfer: From design to production. • Manufacturing processes applicable to medical devices. • Production control of medical devices. • Applications, deployments, qualifications, and monitoring. Methods and tools will be transferable to other industrial fields.