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Simplify Complexity
- Japan regulatory access made easy
Medical Device RAC certified professional
What is SaMD?
What is Software as Medical Device (SaMD)
Software as Medical Device (SaMD) ranges from disease monitoring platforms to diagnostic stand-alone applications (android or iOS app) to unique treatment applications. MHLW Japan and PMDA have unique regulatory requirements that may not be applied to abridged-submission pathways. Our SaMD-focused regulatory experience helps clarify your regulatory strategy from the development to the post-marketing phase.
If you want to know about our services, click HERE.
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