Expertise in testing medical technology
Medical technology research always has been an integral part of the diabetes research performed at Profil. We have over 15 years’ experience performing clinical trials of innovative glucose monitoring, insulin delivery and artificial pancreas products. Since 2012, Profil has had a dedicated Medical Technology department that specializes in the design, conduct and dissemination of clinical trials of medical devices.
We understand how the continuous progress in this field changes the technological and regulatory requirements for medical devices and their clinical evaluations and post-market surveillance, including the recently implemented European Medical Device Regulation (MDR) requirements. Not only do regulatory authorities require solid clinical data from qualified independent test centers for market approval, but also the performance criteria for medical devices are becoming more challenging to fulfill. Clinical medical technology study design requires experience and expertise. Let Profil support you in designing and conducting the diabetes device research and trials you need to bring your medical devices to market.