Note 1: Compliance

Compliance is defined by the level of compliance with the FDA regulations and eCFR. If the device is fully in accordance with regulations it's marked as YES. Otherwise, it should be stated as ALMOST or NO.

See more information on regulation standards on:
Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

eCFR: QUALITY SYSTEM REGULATION

eCFR: GENERAL HOSPITAL AND PERSONAL USE DEVICES

Note 2: Accessibility

Accesibility is defined by the level of access to find the materials for production. If the device only requires 3D printing, this should be marked with EASY. However, if it requires laser cutting and other machinery, or parts that are not easily available on the global market, it should be marked as MEDIUM or HARD.

Note 3: Leadtime

Leadtime should describes the total time takes to reproduce a project. It should be stated in minutes, hours or days.