Regulatory compliance and CE marking support under the EU Medical Device Regulation (MDR) 2017/745, required to place devices on the EU market.
The EU Medical Device Regulation sets requirements for safety, performance, and clinical evidence that manufacturers must meet before affixing the CE mark and placing a device on the EU market.
We support manufacturers through classification, technical documentation, and Notified Body liaison.
Medical device manufacturers, including surgical instrument producers, seeking to place or maintain devices on the EU market.
The regulatory step required before you can sell in this market.
Well-prepared submissions face fewer rounds of questions.
Get the classification and documentation right the first time.
We know what this specific regulator actually expects.
We stay engaged as requirements evolve, not just at submission.
A cleared regulatory pathway makes partners more comfortable.
The same straightforward path applies across every standard and service we support.
Gap review & scoping
Build required documentation
Assessment / submission
Certificate / clearance issued
Tell us a bit about your organization and we'll put together a straightforward, competitive quote.