CONSULTING SERVICES

Our company provides regulatory and quality services for medical devices  and in vitro diagnostics on a global scale. With a team of experienced  professionals, we cater to the needs of medical device and IVD  manufacturers, offering comprehensive regulatory consulting and quality  affairs services to ensure compliance with national regulations. 

Performance evaluation is a requirement in the In vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
It  refers to an assessment and analysis of data to establish or verify the  scientific validity, the analytical and, where applicable, the clinical  performance of a device.

To legally market an in vitro diagnostic medical device in the EU,  manufacturers must comply with the requirements outlined in the IVD  Regulation. This includes providing clinical evidence that supports the  intended use of the device, which should be based on an ongoing process  of performance evaluation.

Performance  evaluation shall demonstrate the scientific validity, analytical  performance and clinical performance of the device and it shall follow a  performance evaluation plan. The clinical evidence derived from the  performance evaluation shall provide scientifically valid assurance that  the relevant safety and performance requirements of the IVD Regulation  are fulfilled.