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.
- Tutorial on Quality by Design (QbD) - coming soon
- Tutorial on Risk Analysis based on ISO - coming soon