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.

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Milestone

Requirement

Preliminary Indications for Use

A description of the way the solution is intended to be used and indications for when it is to be used.
The way a solution is intended to be used will have a major impact on the regulatory pathway. For example, if you are intending a solution to diagnose a medical condition, it will require much more proof than if it reports a value which clinicians use in making a diagnosis.
“Indications for use” describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. To be determined substantially equivalent, the device's indications for use must fall within the intended use of the predicate device.

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A guide to talking with healthcare providers
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are shifting focus to the sister In Vitro Diagnostic Regulation (IVDR) that became...
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Google research on how hospital admins make purchasing decisions
THE ULTIMATE GUIDE TO ISO 13485:2016 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES - Greenlight Guru
IVD Specific Resources
Greenlight Guru guide to design controls for medical devices

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