The purpose of all medical devices produced is to provide significant improvement in the patients’ quality of life. It is expected that the risks of products introduced to the market are less than their benefits and that such a fact is proven by manufacturers.
Following the publication of Medical Device Regulation MDR (EU 2017/745) and in vitro Diagnostic Medical Devices IVDR (EU 2017/746), the pressure on manufacturers regarding the provision of sufficient clinical evidence is increasing day by day. The safety and usefulness of the product is expected to be continually examined and proven using clinical data to be obtained during the life-cycle of the product.
The expert staff at DeSia
- Prepares the most appropriate post-market clinical follow-up (PMCF) plan for you using the outputs of your clinical data evaluation.
- Organizes Clinical Follow-up with your team.
- Reports the generated results.
You can benefit from all PMCF services for your product and also, DeSia experts will assist you regarding the PMCF implementation for which you would like to receive support.