In vitro diagnostic medical devices

Together with you, we develop the core of your technical documentation – a comprehensive performance evaluation that provides clinical evidence and confirms your product’s compliance with the general safety and performance requirements (GSPRs).

We support you in planning and conducting clinical performance studies to close any gaps in your clinical evidence.

We prepare individualized, solution-oriented plans and reports to ensure continuous monitoring of your product’s safety and performance after it has been released to the market.

We assist you in streamlining your product’s risk management, aligning your instructions for use with IVDR requirements, and updating your documentation to reflect the latest state-of-the-art.

Are you considering launching your product outside the EU? Our International Regulatory Affairs team is ready to support you with regulatory approvals in the USA and Canada by identifying suitable pathways and guiding you through the entire process.