EU Medical Device Regulation
(MDR 2017/745)

eu mdr

At 3i Concept, we specialize in providing expert consultancy for businesses seeking to file with the notified body in accordance with the EU Medical Device Regulation (MDR 2017/745). Our team of seasoned professionals ensures a smooth, compliant process, helping you navigate the complexities of regulatory requirements.

Our Services Include:

  • Regulatory Strategy Development: Tailored advice to ensure your product meets EU MDR standards and gets approved without unnecessary delays.
  • Documentation and Submission Support: Comprehensive assistance in preparing technical documentation and filing submissions to notified bodies.
  • Compliance Gap Analysis: In-depth review of your existing processes to identify areas for improvement, ensuring full adherence to the latest regulatory guidelines.
  • Ongoing Support and Monitoring: Continuous guidance throughout the lifecycle of your medical device to ensure sustained compliance.
  • Partner with 3i Concept: Streamline your path to market and confidently meet EU MDR requirements, while focusing on innovation and bringing your products to patients.

Looking For General Support​ For Your Medical Business?

Let’s discuss your upcoming project.