Healthcare Innovation Cycle for "MedTech" Solutions

MedTech is broad term for electro/mechanical medical devices. Tracking data has been added to show 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 of what is involved in completing a requirement 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.

Download a complete 
checklist.

Note: Download and open the PDF so that it is fiilable

MaturityDisplay

Requirement

Essential Requirements Checklist

Detailed description of the clinical and non-clinical data/ information required for the regulatory submission package.
Collecting the data needed to complete an FDA submission package is a very costly exercise. You need a plan that provides direction for activities and sequence them to address the highest risk items as early as possible.
Usually requires working with a regulatory specialist.

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Regions/Markets