Case studies
Transitioning to MDR
Product risk class
- Class I
Company size
- 1 employee
Task
- Transition from MDD to MDR
- Recommend and implement an online QMS platform
CE approval for new intended use
Product risk class
- Class IIb and a Class IIb implant
Company size
- 3 employees
- 2 external consultants, incl. RAQA
Task
- Insource technical documentation from the contract manufacturer
- Transition documentation from MDD to MDR
- Locate and communicate with the Notified Body
- Submit documentation for approval