Medical devices · Foundation
Medical devices: Scope and decision
A product family can contain different models, software and intended applications. Evidence for a related configuration or setting may be persuasive without establishing the suitability of the actual device being offered for the purchaser's stated clinical use. Working output: A configuration evidence matrix showing the proposed use, supporting records and review decisions, with assumptions about related products kept distinct from verified evidence for the offered device.
30 min planned learning scope5 lesson sections5 knowledge questions
After this module you can …
- Identify the proposition the configuration evidence matrix needs to support, with particular attention to “the proposed use”.
- Create the specific working output with concrete entries: A configuration evidence matrix showing the proposed use, supporting records and review decisions, with assumptions about related products kept distinct from verified evidence for the offered device.
- Check the planned effort for the configuration evidence matrix and assign the outstanding evidence decision concerning “the proposed use”.
Checking your access.
Original sources for this topic.
Use these sources to check your own approach. The learning material is independently written by Vergabezone; third-party course content is not reproduced.