SaMD (Software as Medical Devices) is software used to treat, diagnose, and prevent diseases.
Micron has a strong track record in supporting the development of SaMD, and can propose optimal and shortest processes.
Micron can also be a MAH (Marketing Authorization Holder) or a DMAH (Designated Marketing Authorization Holder) .
We are the only CRO in Japan who can support you consistently from development support to sales with a second-class marketing license for medical devices.
Micron can support your needs by using our strengths as a MAH (Marketing Authorization Holder) and a DMAH (Designated Marketing Authorization Holder).
For SaMD development consultation, please contact a specialized CRO.
What is required to market the SaMD* (AI based medical image diagnostic assistance software) in Japan??