[00:00 - 00:16]
Yeah. So Harmonic Bionics is a startup company that focuses on robotics, our primary robot is Harmony SHR, and that is to help people with either neurological impairments or muscular impairments rehab their shoulder.

[00:16 - 00:52]
So our customers are primarily going to be rehab physicians or hospitals, rehab facilities and the people who will be using it. Our patients are going to be people who've, for example, have stroke Guillain-Barré or other neurological disorders or even just injuries, sports injuries where they don't have the proper mobility in their shoulder in the beginning of Harmonic Bionics, we were very research focused company really focusing just on the development of the robot, ensuring that what we were building is something that would work.

[00:52 - 00:57]
And so when I started, we actually started to move towards a more quality focused organization.

[00:57 - 01:16]
And so we have to follow the FDA 21 CFR 820 it's not required by the FDA to follow ISO 13485 or 14971 or ISO 9001, but those are heavily recommended. And so we also try to follow compliance to those ISO standards.

[01:16 - 01:32]
I think we also are moving looking at IEC 60601 62304 from like a software and robotics side. And so there's a lot of different standards and regulations that we need to follow and keep compliance too.

[01:32 - 01:43]
We noticed a lot of gaps in what would be needed in order to take our company from research focus to medical device compliance focused, regulatory focused.

[01:43 - 02:10]
And so with that involved, you know, noticing those gaps was, you know, there was a lot of focus on change control documentation. But there was difficulty in the communication of change control and actually documenting what changes were being made. So I noticed that was a big difficulty and a lot of the users didn't quite understand the importance of something as simple as change management, for example.

[02:10 - 02:38]
I keep going to that because that was, I think, one of the biggest pain points. And of course there is documentation being lost having to be rewritten because it was lost and being able also, we had some individuals who were working remotely or from different areas to have people who were in different states having to come down and physically sign something or use DocuSign or something like that, that was a big pain point for us.