Micron

Introducing Micron’s SaMD Support Package

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 provides SaMD Development supports in most optimal and shortest processes. Micron's services of support package including PMDA Consultation, Clinical trial, Medical device application, MAH or DMAH, Reimbursement and Distribution. Market authorization holder, designated market authorization holder.

 

 

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.

 

 

 

Services includes consultation for applications, PMDA consultation, Survey for predicate device, Protocol creation support, Creation of SOT, Stand alone performance test, Preliminary test, Interpretation test, Statistical analysis, Prepare CSR, Create STED, Application for National Health Insurance. (modalities including CT, MRI, Endoscope, Ultrasound, Skin Photo, Pathological Images.)

 

 

Micron can support your needs by using our strengths as a MAH (Marketing Authorization Holder) and a DMAH (Designated Marketing Authorization Holder).

 

 

Micron owns ISO13485:2016 certification and second-class medical device marketing license. Micron assists obtaining medical device certifications and approvals for SaMD.

 

 

 

For SaMD development consultation, please contact a specialized CRO.

 

 

 

Related:

What is required to market the SaMD* (AI based medical image diagnostic assistance software) in Japan??

CONTACT