Design controls

At the design validation stage, we set up a project plan and handle the Verification & Validation (V&V), providing protocols, execution & reports for a successful regulatory submission.

The project plan, taking into account Risk Management, also considers V&V. V&V encompasses all the design controls required by the FDA to ensure the medical devices you manufacture are safe, effective, and fit the intended use. Often, they happen in combination, with verification occurring during the medical device design process and validation happening at the end. Our experts will provide you with protocols, execution and reports to satisfy these regulations easily.

In the event that the V&V is not approved, Eurofins Medical Device Consulting can help you establish a new design plan, thanks to design review and design transfer.

We help you to meet regulatory requirements starting from the design stage: when setting up a project plan, providing regulatory requirements for your Verification & Validation (V&V), writing protocols & reports for a successful submission, from FIH (First In Human) until market.

We establish the risk management process for you.

If the services of an external laboratory are needed, our experts can help you to find a trusted testing partner that suits your needs and to develop a testing plan and/or protocol, including sterilisation validation and batch release, biocompatibility, transportation, shelf life, packaging and sealing validation, cleaning validation and reprocessing, and more.

Our experts establish a complete Design History File (DHF) and can guide you through the design transfer process in-house or by contracting a manufacturer.