target group
Managing directors and those responsible for quality management and regulatory affairs from micro-enterprises or companies with up to 15 employees.
content
The compact course, which is specially designed for micro-enterprises, clearly shows which pragmatic approaches are necessary to meet the requirements of the EU MDR even with limited resources. The focus is less on pure theory and more on practical implementation and a basic understanding of the necessary steps. The EU-MDR is not considered in isolation, but communicated in connection with the required quality management according to DIN EN ISO 13485:2016 and an appropriate risk management system. The focus is on medical products in risk classes I to IIa. The compact course consists of five full-day seminars in which a main product file, i.e. a kind of "MDR toolbox", is created using detailed templates and practical exercises.
Topic overview & dates
06/20/2022 Product certification in Europe | Basic requirements | Important authorities
06/21/2022 Operational requirements | Quality Management | risk management
06/22/2022 Construction of EU MDR | Economic Actors | Product Classifications | conformity assessment
06/23/2022 Technical documentation | Basic safety and performance requirements
24.06.2022 Post- market surveillance | Reports to authorities | registrations
Test.
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen
