target group
Managing directors as well as development managers, production managers, QM representatives/managers and product managers, employees of regulatory & clinical affairs.
content
As soon as a medical product is created, the course is set for its success. This seminar conveys concepts and procedures on how to create a medical product that conforms to requirements, that does not ruin companies until it is approved and then brings benefits: from the product idea to the approval and reimbursement concept, feasibility study, requirement and design specification, functional model and prototype development to design transfer , pilot series production, verification and validation, series production, application, market observation, maintenance, repair, product care and finally discontinuation. An important aspect is digitization in the individual life cycle stages.
topic overview
- Overview of the product life cycle of medical devices
- Regulatory requirements and their implementation, taking into account a target-oriented digitization strategy
- in the idea and concept phase
- in development
- in the serial transfer
- in the verification and validation phase
- in application and market observation
- in the product maintenance phase
- when setting up the medical device
- Case studies showing which pitfalls can occur in the product life cycle and which solutions are available.
previous knowledge
Basic knowledge of the product life cycle of medical devices and the relevant processes.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
