Regulatory Affair Projects
Project plan for the development of an app for detection of environmentally friendly food
2020 - UniTransferKlinik Lübeck
A project plan was carried out for the cicle of live of an APP. This plan contains work packges from the development phase to the deployment of the app and its care and maintenance.
Concept of a device for pumping reagents in disposable analysis systems
2016 - Universität zu Lübeck & Fachhochschule Lübeck, Germany
The project was completed in conjunction with an international membership group in which model V was implemented to develop the concept for a disposable agent pumping device. The design phase was customer requirements, technical requirements, device design, verification and validation of the project.
Documentation of an EKG design
2016 - Universität zu Lübeck & Fachhochschule Lübeck, Germany
This report was created in comform the IEC-60601 Standard. First the requirement specification was the elaborated. According to this standard, it was classified the project as class II, furthermore the appied parts of the EKG are classified as BF. A block diagram was implemeted with all the stages of the EKG with the insulation diagram. At the end, the test of validation and verification were described.