Clinical Trials

Course contents

- Overview on relevant standards for medical products
- Risk management for medical device development
- Control, measure and analyze according to ISO 9001
- Requirements and verification of medical instruments
- ISO 14155 Clinical trials for medical products
- Regulatory and legal basis for running a clinical trial
- Design of clinical trials
- Collecting data in clinical trials
- Storing and processing of clinical trial data
- Monitoring of clinical trials
- Analysis and reporting clinical trials
- Good Clinical Practice (GCP)
- Requirements for In-vitro-Diagnostics

Department

Master's program Medical Technologies