Testing, trials, usage and disclaimers missing on documentation.

[kny5]

Hi Electronic Cats team,

I would like to contribute to the project by helping on the documentation process for the trials, testing for the design process, and for the documentation related to Open-Source medical devices, and regulations.

Key questions:
Is there any material available detailing the light source calibration, contrasting and trials used by the design team?
Is there a working paper relating the design, trials and usage?
Is the testing process and trials data opened and detailing how does the device reduces the risks or increases the success in medical I.V. interventions?

Notes:
As a medical related device an assessment on risks and responsibilities in the usage and proper instructions are needed with the release.

References:
https://www.appropedia.org/Open-source_3-D_printable_autoinjector:_Design,_testing,_and_regulatory_limitations
https://www.appropedia.org/IV_placement_and_Management

Kind regards,