Developing a Medical Device – A Process in Five Phases

Developing a medical device (MD) is a complex and often challenging process. This is particularly true for high-risk medical devices affected by the EU’s current regulation 2017/745.
The process of developing a medical device can be divided into five phases. Providing a full set of high-quality services to guide developers in this process is TBMED’s major goal. To this end, TBMED offers a set of tutorials to give developers direction and hands-on advice throughout the different phases.

Explore in detail by moving your mouse over the phases
image/svg+xml1.ConceptPhase2.Prototype Optimization3.Prototype Validation4.Clinical Proof of Concept5.Clinical Investigation

Tutorials

Phase 2
  • Tutorial on Quality by Design (QbD) - coming soon
Phase 3Phase 4
  • Tutorial on Risk Analysis based on ISO - coming soon