SaMD Development Support​

SaMD Development and Commercialization Support in Japan

Software as a Medical Device (SaMD) refers to software-based medical devices used for the treatment, diagnosis, or prevention of diseases.

Do you face any of the following challenges?

• Uncertainty about whether your software qualifies as SaMD
• Not knowing where to start consultations with the PMDA or certification bodies
• Progress in development, but concerns about approval, certification, or commercialization
• Wanting end-to-end support in Japan, including MAH/DMAH arrangements

In Micron we addresses these challenges by leveraging its extensive experience in SaMD development support and regulatory expertise, proposing the most efficient and shortest development pathways tailored to each product.

More than development support. Full-lifecycle SaMD support as an Imaging CRO.

SaMD Services Supporting the Entire Lifecycle from Development to Commercialization

Micron provides the following services with a comprehensive view of SaMD development through commercialization.
As a CRO holding a second-class medical device marketing authorization, Micron is capable of acting as MAH or DMAH for Class I and Class II medical devices.

Our strength lies in a one-stop support framework that goes beyond development support, enabling seamless progression from development to commercialization.

Depending on the development stage of the product and business strategy, services can be flexibly combined as needed.

• SaMD Applicability and Development Policy Review
• Regulatory Compliance and Classification Review
• Consultations with PMDA and Certification Bodies
• Clinical and Performance Evaluation Support
• Software Development Process Support (Compliant with JIS T 2304/IEC 62304)
• Approval and Certification Application Support
• Business License Acquisition and QMS System Establishment Support
• Manufacturer and Marketing Authorization Holder(MAH/DMAH)
• Insurance Coverage and Market Launch Support
• Post-Market Surveillance and Safety Management Support

1. SaMD Applicability and Development Policy Review

We confirm whether the product qualifies as Software as a Medical Device (SaMD) and clarify its clinical positioning. By identifying key issues early in development, we help establish a development strategy with approval and market launch in mind.

2. Regulatory Compliance and Classification Review

Taking clinical significance and potential risks into account, we assess generic names and device classifications. We organize domestic and international regulatory requirements and clarify the optimal regulatory compliance strategy.

3. Consultations with PMDA and Certification Bodies

Based on the development strategy and evaluation plans, we support the preparation of consultation materials and responses for consultations with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and certification bodies. Our support is tailored to the project’s stage, from preliminary to formal consultations.

4. Clinical and Performance Evaluation Support

Leveraging our expertise as a CRO, we provide clinical and performance evaluation support tailored to the characteristics of SaMD, including computer-aided diagnosis (CAD) systems for medical imaging.
In SaMD development, consulting and clinical development are often handled by separate organizations, which can create the need to identify a new support partner at the clinical trial stage.
At our company, our in-house SaMD team works closely with the clinical development department to deliver seamless, end-to-end support—from evaluation planning and execution to data analysis.

5. Software Development Process Support (Compliant with JIS T 2304/IEC 62304)

We support the organization and documentation of software development processes in compliance with JIS T 2304 and IEC 62304. Our services help establish development frameworks that incorporate the quality requirements for medical devices, while ensuring alignment with clinical evaluation and regulatory compliance.

6. Approval and Certification Application Support

Based on evaluation results, we assist in preparing and submitting application documents for approval, certification, and notification. We support the entire process, from application preparation to responding to regulatory inquiries.

7. Business License Acquisition and QMS System Establishment Support

We support the acquisition of business licenses for manufacturing and manufacturing/marketing authorization, as well as the establishment of QMS frameworks. Our practical support helps build the infrastructure required for SaMD development and market launch.

8. Manufacturer and Marketing Authorization Holder(MAH/DMAH)

We support the smooth realization of manufacturing and marketing, with a comprehensive view of the entire process—from development through post-market activities.

9. Insurance Coverage and Market Launch Support

We support the smooth realization of manufacturing and marketing, with a comprehensive view of the entire process—from development through post-market activities.

10. Post-Market Surveillance and Safety Management Support

We provide continuous support for post-marketing safety management and change management, focusing on post-launch operations. Our services cover the entire product lifecycle.

Track Record