Assessment roadmap · in development
Is My Software a Medical Device?
This page reserves the structure for Pacific Access Medical’s future interactive software assessment. It does not currently collect answers or generate a regulatory outcome.
Planned question flow
Five stages from product concept to the next regulatory question
The structure separates medical-device status from exclusions, exemptions and classification so that visitors do not mistake one answer for the complete pathway.
- 01
Intended purpose
Describe the product, user, patient population, medical purpose and claims.
- 02
Software functions
Identify inputs, analyses, outputs, recommendations and any connected medical devices.
- 03
Clinical influence
Consider who acts on the output and the potential consequence of an incorrect result.
- 04
Exclusions and exemptions
Screen for relevant software exclusions and the limited CDSS exemption.
- 05
Indicative next question
Receive a cautious pathway prompt—not a regulatory determination or classification certificate.
Learn while the tool is built