A Clinical Investigation is a systematic assessment involving one or more human subjects, undertaken to evaluate the safety and performance of a Medical Device (MD). In principle, all Class III and implantable MDs should undergo a Clinical Investigation unless an exception applies.
How can DDR help?
- DDR will assist with the design of these investigations and provide times and costs.
- DDR will introduce you to well-renowned Contract Research Organizations (CRO) that specialize in the field of devices.