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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MaturityDisplay

Requirement

Finalized cGMP Production Environment

Complete key Quality System documentation and applicable processes necessary to comply with domestic and any international Good Manufacturing Practices (GMP) requirements for your product.
Quality System documentation and implementation of key processes is how regulatory agencies manage medical devices.
Utilize documentation such as ISO 14385 and other applicable regulatory documents for your product to identify key QS requirements.

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Resource Type
Regions/Markets