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

Requirements

Data Requirements Confirmation
A thorough review and critique of the non-clinical and clinical data requirements.
GDPR-HIPAA Compliance
Compliance with appropriate data privacy laws
Pre-Submission Filed
A pre-submission and meeting with the regulatory body to review testing required and confirm which you will plan to submit.
Security and Vulnerability Certifications
Certifications that the system passes penetration and other security tests