Validation and Safety

Internal Research Portal

New regulations (MDR) impose even stricter requirements on validation and verification of health technology. Health tech measurements in hospitals are impossible without certification, Certification is impossible without clinical trials, a catch-22. This expertise and knowledge to break that cycle with tools/methods need to become standard for all researchers. This can be performed (pre-clinically) in the test/simulation facilities at the UT reducing the time/expenses for clinical studies like costly RCT’s. For clinical studies - but also for public health research - specific tools/methods are available or can be developed to acquire qualitative & quantitative data to prove the effectiveness of medical technologies. For measuring the adoption and impact on society, an integral assessment methodology will be used, rooted in social sciences and engineering creating added-value