Where Clinical Practice Meets Engineering
Excellence

We combine medical practice and technical expertise to help companies bring products to market under EU MDR. 

 

MDR Consultancy

We guide the full journey from concept to market launch under EU MDR:

  • Device classification & Intended Purpose

  • Risk analysis & FMEA

  • Design verification & validation

  • Clinical evaluation & trials

  • Technical documentation

Medical Device Design

From idea to tested prototype, with clinical and technical expertise:

  • Design & development of medical devices 

  • Perfusion systems, surgical simulators

  • AI models

  • Validation in wet tests for a realistic user environment

Products

  1. Devices in interventional cardiology

  2. Devices in cardiac surgery

  3. Beating heart models for design validation

  4. Heart simulators

  5. AI models

We are open for other medical products as well.