MDR – Medical Device Regulation
The EU Medical Device Regulation (MDR, EU 2017/745) has set new standards for the regulatory requirements of medical devices on the EU market. The regulation imposes strict requirements on safety, traceability, and clinical evidence to ensure products are safe and effective.
We assist you with:
- Ensuring your documentation, including the technical file and clinical evaluation, meets MDR requirements.
- Preparing for and managing notified body reviews.
- Implementing efficient systems for post-market surveillance and risk management in line with MDR guidelines.
With experience ranging from small companies to large multinational organizations, we can guide you through every step of MDR compliance, from strategy to implementation.
Need assistance with MDR? Contact us today to ensure your product remains competitive and compliant on the EU market.