How a configurable QMS helps engineers
Highlighting the practical challenges engineers face, Michael Hogan emphasizes the value of a tailored QMS. With Unifize, they had a system that catered precisely to their needs, without unnecessary overhead or constraints. The flexibility to mold the QMS to their unique processes proved invaluable, contrasting starkly with other restrictive systems they'd encountered.
Transcript

00:00 - 00:07
I would say that what you get is a system that does what it needs to do and nothing more.



00:07 - 00:38
Right? We basically got the system out of the box that we configured to the processes that we needed. There was no extra overhead. It was exactly what we needed and there was nothing else because we made the processes that we're following. Right? You literally cannot get more streamlined than that. Any other system that we'd be using is putting us into this box that our company doesn't fit into and the ability to make your own QMS, I think, is useful.



00:38 - 00:44
The biggest thing about any quality system right, is that they tend to grow and proceduralize. I think that,



00:44 - 01:08
you want to minimize the number of gates or roadblocks that are between, you know, my goal as the engineer to make some improvement or some design update or resolve some issue that we've identified and acting on that change. Right. How do you have as few roadblocks as possible while still capturing all the information that you need to get regulatory perspective and make sure that you're following a correct process?



01:08 - 01:27
I think that fundamentally the thing that Unifize does very well about that is that the processes are so customizable that if I find something I don't like, I can go talk to the quality engineer and say, Hey, we need to change this. This is this is wasting people's time. And usually we can sit down and agree on that.



01:27 - 01:39
Or maybe there's something I didn't realize. But you know, any individual process has to stand on its own merits or we can cut it right. There's nothing that locks us into anything with Unifize, which I think is really nice.

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Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

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