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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.

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If you want to know about our services, click HERE.

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