IVD Regulation services
Regulatory IVD services
Are you developing or selling in vitro medical devices or companion diagnostics? Qserve helps IVD manufacturers in all product life cycle phases to get IVD compliance and to keep the product on the market according to IVD regulations in different countries. Every step in the design and development process for IVDs can be completed and helps you to get regulatory approval.
Our IVD consulting experts fully understand the EU IVDR regulation, the transition from IVDD to IVDR, the FDA IVD requirements in the US, and pre-submission review, which can help you enter the US medical device market sooner and directly through the proper route to the FDA.