Tuttlingen – The EU-MDR, which has been mandatory for nine months, continues to pose a major challenge, especially for smaller companies. A compact course that starts on March 14 is specially tailored to them – in order to convey an “optimum”, the requirements being pragmatic to be able to implement leanly.
Many years in clinics, industry and quality management: Karl-Heinz Fischer knows the medical technology industry inside out - and thus also the needs of small companies in particular. This experience flows into the compact course "MDR - Toolbox for Lean Implementation". The focus is on the certification of class I to IIa medical devices. When Karl-Heinz Fischer opens the tool box, he provides templates, for example. "They are kept relatively general and can be tailored to your own needs and used in your own company without great effort," says Karl-Heinz Fischer about the "tools" to deal with certain chapters of the EU MDR. One thing is particularly important to him: "To convey an optimum that you can live with." Means: not too little, but also not too much implementation - to economize with the available resources in the company and to use them efficiently. Likewise, the exchange between the participants should not be neglected. "It's important that your own examples are included and discussed in the compact course," Karl-Heinz Fischer encourages to use the platform for dialogue - so that the participants know directly and specifically where to use the newly acquired tools even better can be applied.
The contents of the compact course in detail:
03/14/2022 Product certification in Europe | Basic requirements | Key Authorities 03/15/2022 Operational Requirements | Quality Management | Risk management 03/16/2022 Structure d. EU MDR | Economic Actors | Product Classifications | Conformity assessment 03/17/2022 Technical documentation | Essential safety and performance requirements 18.03.2022 Post-market surveillance | Reports to authorities | registrations
