Post-market surveillance

Guaranteeing the safety of your devices

Your device is already on the market. We make sure that you are always aware of how it is performing. You are notified of any complaints in good time and can react immediately and responsibly.

Medical device vigilance system

You would like help processing complaints and wish to set up and optimise your medical device vigilance system in accordance with MEDDEV 2.12.1 rev6? Then you should place the important and time-consuming task of market observation in our capable hands. We will support your safety officer in accordance with Section §30 MPG (German Medical Device Act) and help you with any necessary medical device reporting to DIMDI (German Institute of Medical Documentation and Information), BfArM (Federal Institute for Drugs and Medical Devices), or the FDA.

Risk management

You would like to receive assistance in risk assessment and set up an effective risk management system according to DIN EN ISO 14971? We will help you to create a system that meets all regulatory requirements. We will support you in the preparation of your risk assessment and moderate it competently and professionally.

Post-market clinical follow-up (PMCF)

Do you need help evaluating your devices on the market? We support you in the establishment of your post-market clinical follow-up system in accordance with MEDDEV 2.12-2. In addition, we conduct proactive literature research and literature surveillance on your behalf and evaluate your device according to clinical, technical and biological criteria.