Huda is a medical engineer with a focus on Risk Management (ISO 14971) and Medical Device Regulation. During her studies she gained knowledge in biology and chemistry as well as in Quality Management (ISO 13485), Usability Engineering (ISO 62366) and Requirements Engineering. In her studies in biomedical engineering she created a clinical evaluation for the medical device Reha-AquaBike and afterwards in an internship she revised the QM documents for the same product. Besides her studies she did various internships, where she gained experiences on the handling, maintenance as well as the refurbishment of medical devices and the reviewing and revising of medical device files.
Expertise
- Risk Management for medical devices
- Usability Engineering
- Writing clinical evaluation
- Medical device manufacturing, inspection, refurbishment and maintenance
- Reviewing and revising medical device files