Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485, page-47

So this is a great question. ISO certification in all areas is about basically "paperwork".

Meaning that regulatory bodies have documented proof that what the company says it does is actually correct and that there is a verified and audited paper trial to prove it.

So the regulatory bodies can at any time ask for and receive every piece of paper that may include designs, design decisions, trial paperwork, application changes and literally everything to do with the company so it can be audited and re-verified if needed. Even Board minutes and team meetings.

It is not about the product itself or the algo in this case....it is about the journey. How did the company get here? Did they take any shortcuts? Are their management and operational processes meeting the standard to keep their ISO certification etc etc.

For RAP.....While its not so much about RespapDX itself....its more about how other companies will see ResAppDX because of the certification.

If someone was to sign a contact with us to use ResAppDX...they are more or less assured that what they signed up for is what they will get because we are ISO certified....and not some fly by night mob who promise big and deliver nothing.

It really is the gold standard for companies to achieve because its wonderfully trusted worldwide.

I don't think that because this certification is coming after the trials that it makes any difference at all.....it only enhances it in the eyes for regulatory bodies.