In order to be placed on the market in the European Union, a medical device or IVD device must be CE marked. As a requirement for obtaining the CE marking, a clinical trial must be performed by the manufacturer of the medical device. If the clinical evaluation requires a clinical device trial, you can have it performed by us. A clinical device study evaluates the performance of a device (performance and safety) in the right operating environment & in the right patients.
First, your company draws up a research plan for how the research will be conducted, describing how the research will be carried out. You may also, if you so wish, outsource the execution of the research plan to an operator providing clinical research services.
After receiving your research plan,we select the researcher in charge of the research and assist in applying for a research permit and ethical review. Patients are recruited and the study is conducted at HUS according to the study plan. The responsible researcher is always either a doctor or a dentist.In conducting clinical device trials, we comply with the law and the provisions of the authorities. We will notify Fimeaof a clinical device study before starting the study.
Report as agreed in the research plan. Reporting of results may also involve the publication of scientific publications. This will be agreed upon separately.
An agreement is made with HYKS-instituutti Oy for the assignment. All externally funded research at HUS that involves HUS patients and / or resources is managed by the HYKS-instituutti Oy.