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I think the attitude you approach this company with highlights one of the major causes of the unjustifiably high medical costs in the US. Many of your critiques are based on status quo expectations that are, for the most part, non-issues.

Yes, these devices are of a lower quality than devices with prices 10-100x higher, but they get the job done, which is what actually matters. Some new practices will have to be designed to properly decontam and maintenance them, and experimentation to figure out their tolerances, but there are many more medical practices in the world that need these devices than have them; the main issue is cost.

"However, it does not talk about bio compatibility of the material used, potential contamination during manufacturing process, what kind of disinfectants can be used on the product, what is the operating range in terms of pressure, temperature, humidity, etc"

Working in hospital infection control, this was one of my first concerns as well.

> I am not sure how you could pass an audit if your documentation contains "Lorem Ipsum" [2]

In a lot of industries there’s a huge conflict of interest as the auditee is also the company paying the auditors.

If the auditee loses a certification / accreditation, that’s also a loss of business for the auditor.

> If the auditee loses a certification / accreditation, that’s also a loss of business for the auditor.

A bunch of simple medical devices (Class I in the EU) are self-certified by manufacturers, and require no seal of approval before commercialization.

Because they can cause no harm, otherwise they would be in Class II.

Does US class 1 require - "complaint handling unit, to raise and analyze every adverse effect on the field, and report to regulatory bodies the worst hazardous case in a limited time frame, be able to do recall and so on." - Don't know so I'm asking. I would assume any product with class 2 has these requirements. My assumption under class 1 is that you need to be able to determine you built the product to a predefined set of specifications.

The device is registered in Canada and I found that information [0] :

>For all devices except Class I, implement an ISO 13485:2016 under the Medical Device Single Audit Program (MDSAP) compliant quality management system, which includes the specific requirements of the CMDR. ISO 13485 certification, used to demonstrate compliance with European regulations, does not meet Canadian requirements. Updates to the existing procedures, or new procedures, must be implemented.

So it seems you don't need to implement post market surveillance for a class 1 device or having a complaint handling unit.

[0] https://www.emergobyul.com/resources/canada-process-chart

Yes. Complaints are part of the Quality System Regulation that all device manufacturers selling in the US must abide by.

The devices they currently market are low risk (across US, Canada, EU, etc) so there is minimum regulatory burden. The "working on it" note regarding a Pulse Oximeter mentions a clinical trial, which I infer to mean that they're considering regulatory requirements for higher-risk or more complex devices.