Working Groups
Due to a multitude of specialist topics and the high complexity of the details and interrelationships within the data model, it was clear from the beginning that the development of the data model could only be realised with the support of the entire MedTech community.
Only together can we devote the necessary time and expertise to develop such a comprehensive data model and keep it up-to-date.
To date, the following working groups have been established for the development of the data model:
Data Model
Usability
Engineering
PMS & Vigilance
Product Development
Clinical evaluation
and PMCF
Risk Management
Clinical
Investigation
Technical Documentation
Further working groups planned:
Labeling
Software Development
Cybersecurity
Electrical
Safety
Biocompatibilty
Design transfer &
Documentation
Each working group consist of 6-10 members which regularly meet online and work on topic-specific tasks. Two working group members co-lead each group and also ensure the exchange with other working groups. Meetings of the group leaders are organized at reglar intervals to share best practices, discuss challenges and new ideas. The time commitment for active participation in a working group is 2-4 hours per month, for team leads 4-5 hours.
MDKU Medical Device Knowledge Units e.V.
Am Weichselgarten 7
91058 Erlangen
Germany