Problems I faced with other eQMS that Unifize solved
Michael Hogan candidly shares his past frustrations with traditional QMS platforms. Recounting experiences where designs were sent into a seemingly endless void, only to receive feedback weeks later, he stresses the inefficiencies of such systems. For dynamic startups like Harmonic Bionics, where agility and promptness are paramount, a responsive and interactive QMS like Unifize became indispensable.

00:00 - 00:16
The relationship I've had with a quality management system in my previous roles has more or less been: Get your design together, throw it over the fence, and two or three weeks later you might get an email saying that you need to add some field to a part property or something like that.

00:16 - 00:45
There's no communication back and forth. As far as I knew, it was just sending parts out into the void. With a smaller company, you cannot do that, right? There's nobody in the void to send it to. And more importantly like that, those two weeks you don't have. Right. We need to get this stuff out now. And So what I like about Unifize is that I see exactly what's happening with the information or the designs that I am putting forward to get released.

00:45 - 01:18
Everybody's looking at the same files. Everybody has the same chat history. There's no obfuscation of what's going on. And so I think having a common understanding of the process that our parts designs, our deviations, quality notifications are going through is really useful. And I think that, it is a time saver for me because ultimately I need to think about the system less and I can just focus on my job more, right?

01:18 - 01:42
As an engineer, right, my job is to solve problems with the product and make sure that we have a good saleable device that hits the market and does what it needs to it. That helps people. And if I do that, if I do my job as the engineer, the way that we've set up our QMS with Unifize I'm just writing what I've done and that's the process, right?

01:42 - 01:44
I think that's pretty useful.

Unifize Results

Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs

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.

Related Case Study Videos

About Denis Machoka and his role as VP of Quality at Harmonic Bionics
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Near instant implementation and adoption of Unifize
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Experience the benefits of Unifize

4x Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization

70% Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs

10x Speed to compliance

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

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