Inputs
- Current marketed configuration
- Target software capability
- Connectivity, cloud, and data scope
Existing device + software
Before adding an app, see what it changes in the existing device.
Compare the current hardware configuration with the target software configuration and surface product, regulatory, quality, and security questions.
Why it matters
A small feature can change intended use, data flow, cybersecurity, risk management, and existing QMS records.
Controls
- Current and target states kept separate
- Unknowns never treated as facts
- Jurisdiction-specific impact questions
Outputs
- Configuration differences
- Questions by function
- Change-review baseline
Questions, sentences, and documents proposed by Cloqi Doss are working material for professional review. They remain distinct from external approval, submission, and an effective QMS record.