As life support equipment, ventilators must have a high-quality design, with design controls, thorough review, and a well documented verification plan. Our design is developed under an ISO 14971 process, and our software under ISO 62304. We will qualify the device under ISO 60601-1 once the design has reached a sufficient level of maturity. All of these process and design controls are critical to the successful design of a product that will be responsible for a human life. Conforming with existing quality standards facilitates the regulatory approval process for our initial deployment.
For details on component characterization tests, see the Characterization Test Plan.
Documentation relating to the testing equipment, strategy and test data is in the testing subdirectory.
@dburnham gave a presentation (+ meeting notes) about regulatory documentation.
One of the parts of this is Software risk analysis - as begun in this spreadsheet by @jam
There is a tentative outline for user documentation.