Healthcare Innovation Cycle for "Digital Medicine" Solutions

Digital Medicine is a broad term for the subset of the Digital Health field that related to promoting wellness or providing medical care (see Digital Therapeutics Alliance Definition). Tracking data has been added that shows an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description and curated resources.

Note:To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest.

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checklist.

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MaturityDisplay

Requirement

Submission of Technical File to Regulatory Body

The completed data package submitted to the appropriate authorizing regulatory body.
Required for use of non-exempt medical products.
The submission should be executed by an experienced regulatory professional. If you do not have a regulatory professional on your team, it is recommend that engage a regulatory consultant.

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Resource Type
Regions/Markets