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