Why Unifize makes post-market compliance a breeze
In this insightful video, Clarissa tackles the complexities of post-market compliance in risk management, focusing on the medical device sector. She emphasizes Unifize's pivotal role in effortlessly connecting customer complaints to corresponding solutions and risk assessments. Clarissa explains how this integration drastically cuts down the laborious task of complaint analysis, enabling proactive and efficient risk control updates, a feature she finds particularly advantageous.
Transcript

[00:00 - 00:06]
So another aspect about risk management that isn't often thought of, especially in the new product space, is actually post-market.



[00:06 - 00:27]
And so one of the importance is of once you create this whole risk file where you're thinking of all your specifications, how they meet your user needs, and the outputs from that is once it's in the user's hands and if something happens, you know, you're required by FDA and by the law to report any customer complaints.



[00:27 - 00:52]
And so one of the key parts is being able to connect those customer complaints to those solutions that you've come up with. Because, again, your risk, your risk number is your occurrence times the severity. So once you have a legacy product that has history, you're able to see, you know, if your estimated occurrence that you originally did in your FMEA actually matches with the true life.



[00:52 - 01:34]
So when you have a customer complaint, you need to be able to connect it to what that affects and reevaluate and look at. Okay, we've had these complaints and is this something that we need a redesign, Do you need a recall? You know, what do you need to do in order to fix that? And I think again, that's a really huge benefit of Unifize Because at my last company, for example, you know, we the new product Development Quality Engineering group would spend a full year reviewing thousands and thousands of complaints and trying to connect them to the applicable risk analysis and also reviewing to make sure that our risk level was acceptable. And if it wasn't, how we can fix that.



[01:35 - 02:08]
And so, you know, that was several, several months, a year of every week, hours and hours and hours of analyzing all of these complaints to try to figure out where they go. So the ability to as complaints come in, connect them to the direct design input and the direct design output that affected that complaint is huge and that can save hundreds of hours of work in order to be able to automatically see that and trend from there too.



[02:08 - 02:29]
You know, when you have when you're doing this manual process of reviewing the complaints to your outputs and redoing all of those risk controls, you know, you're not able to see trends as they happen. You have to see it after the fact. And so you have to be typically more reactive because you weren't able to see those trends as they were happening.



[02:29 - 02:33]
And, you know, nobody wants to have patients being in pain

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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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