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Webinar with Amanda Amell from Shoebox

Continuous Improvement in a fast-growing Medical Device company

HubSpot Video
Agenda

00 : 02 : 00
Main challenges

00 : 08 : 00
Contiuous Improvement Framework

00 : 13 : 30
Case Study with
Amanda Amell from Shoebox

00 : 42 : 00
Q&A session

How to tackle continuous improvement in regulated industries?

During this 1 hour webinar, we will enjoy the expertise of Amanda Amell, QA expert at Shoebox, who will explain all the ins and outs of continuous improvement in a fast-growing company.

Shoebox is a Canadian Software Medical Device company in the market, going quick as lightning from theory to action globally!

Q&A's from the session

Q: Do you have a system in place to get customer feedback?

A: Customer feedback for us can come in different ways. We have our customer support team or account managers or product managers. They all receive different kinds of feedback. We get complaints, potential software bugs, negative feedback, feature requests. It all flows through a ticketing system. With the ticketing system it gets assigned accordingly. It gets categorized: if it's a complaint it goes through this process, if it's a feature request, it goes through this process. And then we have the complaint process. We talk about customer feedback and post-market surveillance also. Is stuff that we need to monitor and maintain.

We gather data from all sorts of places to discuss and all of these become inputs to our management review and we make sure that we're meeting our objectives. We set out certain objectives to comply with our quality policy. So the customer feedback is important because we need to continuously improve and provide the best product we can, that is safe and effective.

 

Q:  What size as a team need to be for this continuous improvement process to be necessary?

A: We have a fairly small quality team at the moment. We're only three people and we manage to cover a large territory of requirements. Obviously having more resources I think would be more efficient, but that'll come as we continue to grow. You have to evaluate what your business needs are and your customer needs. 

If you are putting on the market a medical device you will need to have a continuous improvement process in place. Even if you're just two persons, you need to have your quality system set up. Otherwise you will not get certified. So that's definitely a requirement. And then the team size doesn't really matter, but you need to have it documented, written down and actually do it right. Show some proof that you actually do what your processes say that you do. So I think it's not about how large should the company be before you implement this. It's really from a business need perspective.

 
Q:  Which steps we can implement in order to encourage continuous improvement in the quality system? Is this just the responsibility of the quality manager? 

A: Everyone needs to be moving towards the same goal. Everyone needs to be involved. Continuous improvement is something that needs to be revisited regularly and it's not just the quality managers responsibility. Everyone needs
to be quality obsessed.

 

 

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