All products developed by Wellspect HealthCare undergo a process where product safety and performance is carefully evaluated.
Figure 1: A research progress illustration for the development process within the clinical trial path from lab to a finished product on the market.
Pre-clinical research and clinical trials are important to establish the safety and performance of new products. The testing program will depend on different factors like knowledge and experience of clinical use of similar devices.
Post-market product surveillance is performed to gain further knowledge about safety and performance of our products in clinical use (use by patient or public healthcare provider) after release on the market.
Ethical aspects are essential and of highest importance. We meet all regulatory requirements when conducting clinical trials. Participation in clinical trials is always voluntary. All Wellspect HealthCare clinical trials are registered on ClinicalTrials.gov.