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 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.
target group
Managing directors and those responsible for quality management and regulatory affairs from micro-enterprises or companies with up to 15 employees.
Topic overview & dates
02/28/2023
Introduction and presentation of the medical device market in Europe | MDR – General Requirements| Product group formation, nomenclature, risk classes| MDR Conformity Assessment Procedures| Timeline EU-MDR| Practical exercises: Creating purpose statements for example products, assigning risk classes, determining the appropriate certification processes
03/01/2023
Structure MDR | Roles of economic actors and their obligations| QAA as a framework for cooperation| The Responsible Person| UDI nomenclature| EUDAMED Databases| Practical exercises: Discussion of the QAA, development of individual QAA elements, test, who can be considered the responsible person? Creation of a product label MDR-compliant
03/21/2023
DIN EN ISO 13485:2016 and the effects on the QM system | The implementation of the requirements for risk management according to ISO 14971| The technical product documentation according to MDR| Practical exercises: determination of risks for selected products, definition of risk-reducing measures, creation of an FMEA and the associated report, validation and qualification measures for production
03/22/2023
Technical documentation according to MDR | Practical Exercises: Preparing a Clinical Evaluation, Basic Safety and Performance Requirements
03/23/2023
Post-market surveillance | Passing the MDR audit, official inspections, etc. | Practical exercises: preparing a monitoring report with the essential elements, identifying trends, incorporating essential points into risk management | 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:
MedicalMountains GmbH
