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The Importance of a QMS for MedTech

There are many benefits to having a QMS, but at the top level there are two main points. Firstly, having a QMS means that you have a guide for how your company should perform specific activities so that you ensure that you are meeting customer and regulatory requirements. And secondly, a QMS provides a mechanism for a company to continually improve its effectiveness and efficiency.

The Importance of a QMS for MedTech

Aljaž Podboršek, Head of Quality at Cosylab, shares his experience about the importance of having a QMS for your MedTech startup.

Before we get into why we need a quality management system or QMS, can you briefly tell us what it is in the context of medical devices?

Yes. That’s a good place to start. In short, a QMS for medical devices is a structured system of documented processes, procedures and responsibilities for managing the different phases in the lifecycle of the device.

So, why is it necessary for MedTech startups to have a QMS?

There are many benefits to having a QMS, but at the top level there are two main points. Firstly, having a QMS means that you have a guide for how your company should perform specific activities so that you ensure that you are meeting customer and regulatory requirements. And secondly, a QMS provides a mechanism for a company to continually improve its effectiveness and efficiency.

I can see if you have clearly documented procedures for how specific activities should be performed, then anyone in the company, knows what to do. This means that training new staff is quicker and smoother.

Exactly. Also, apart from anyone knowing how things are done, you also make it possible for the same activity to be done the same way each time. This means that you can get reproducible outputs and reproducibility is an important aspect of safety.

Tell us more about how a QMS helps improve effectiveness and efficiency.

It’s easier to spot inefficiencies if you always follow documented procedures. After you have executed a procedure a few times, you learn what about the procedure can be improved. If you are not doing the same thing each time, then it is difficult to see where the inefficiencies are. The same applies to effectiveness. If your procedures are not achieving the intended purpose, then it is a bad procedure and should be changed.

The one thing that most people may not be aware of is that your QMS is a living system and part of QMS management is continuous improvement of how activities are performed. If a part of your QMS is not efficient nor effective, then you should change it. At the end of the day, you shouldn’t be a slave to your QMS, your QMS should be working for you.

Does this mean that each company must have a QMS that is tailored to their specific situation?

That is true, but since we are mostly talking about procedures to achieve specific requirements, there can be many similarities. Many medical device manufacturers will be referencing similar regulations and standards, so they can learn from each other in terms of how to construct their QMS. The other important factor is that a QMS should incorporate as many of your existing working methodologies and tools as possible because it is easier to convince people to follow the QMS if they are already familiar with some aspects of it.

We’ve spoken about the high-level benefits of having a QMS, but what are some of the day-to-day benefits?

At the top of this list, since safety in medical devices is so crucial, has to be that a QMS significantly reduces the chances of making mistakes. When you have defined and documented procedures that everyone follows, you make fewer mistakes. And if a mistake does happen, you have a mechanism for analysing and rectifying it in a consistent manner.

Next, it makes certifying your device easier because your QMS is created to take into account all regulatory requirements for your target markets. So, compliance is something you start taking care of very early on instead of right at the end when the device is ready. This also means that if there are changes to regulations, it is easier to incorporate because you will know exactly what the changes impact.

Then, we can look at efficiency benefits where you reduce waste of materials, time and effort which means you lower costs. Of course, the biggest benefit of improved efficiency is that you reduce the time to market for your device.

Some staff-related benefits are that you can use the documented procedures to identify training opportunities for them and since your staff actually use the QMS, they are important for giving feedback on the procedures, thereby being an integral part to the continuous improvement process.

A QMS can also help your funding applications because it establishes a framework for how your business operates and communicates that you are prepared to produce consistent results. Since your QMS defines expectations and deliverables for key processes, investors know what to expect, which could increase their confidence in your company.

Ultimately, having a QMS does improve your company’s credibility.

(Read our news about Cosylab Switzerland, owning the ArrowFast trademark, received ISO 9001 and ISO 13485 certificates.)

Does every medical device manufacturer need a QMS?

Whether you need a QMS actually depends on the regulations of your target market. Generally, most regulations require a QMS if you are developing a medical device with moderate, medium or high risk. However, in my experience, having a QMS always works in your favour, since as I’ve said, there are more benefits than just regulatory compliance.

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When should companies implement their QMS?

Most companies put off implementing the QMS because they are not familiar with the regulations and requirements for a QMS, they don’t have the in-house expertise to set up the QMS or they think it is a waste of time. But, companies should implement their QMS as soon as possible. Simply, the later in the development lifecycle the QMS is introduced, the more it costs.

Can you tell us more about what you mean when you said it costs more the later the QMS is introduced into the development lifecycle?

Well, let’s say you’ve developed your product and you have reached the stage where you are ready to certify it. So, you now set up your QMS. Then, you discover that there are many things that you should have been doing or should have been doing differently from the beginning of the development. In order to get your product certified, you now have to go back and re-do things or you need to fill in the missing pieces.

If you had set up the QMS at the beginning, then you have a better understanding of what is required for certification and it becomes a part of how you normally work. In this way, when you get to the end of the development and you are ready to certify, there should be almost nothing you need to do.

Another area that has costly consequences is making mistakes, and a QMS reduces the chances of mistakes. Finally, most companies have a growth plan, and again by having procedures documented, it is easier to identify the bottlenecks as the company grows.

Can you offer some advice about how companies should go about setting up their QMS?

This one’s easy. The overall process for setting up a QMS for medical devices is quite straight-forward. We’ve separated it into five main steps with the goal being that you get a certified QMS:

  • Decision and planning
  • Analysis and documentation
  • Implementation, control and measurement
  • Internal Audit
  • Informal External Audit and Certification

We've prepared a blog 5 Steps for Setting up a QMS for Medical Devices that describes these five steps more thoroughly.

And, of course, ArrowFast is able to help you answer any specific questions you may have. Just contact the quality team at regulations@arrowfast.tech.

Thank you, Aljaž. Do you have any final thoughts?

Set up your QMS early so that quality becomes a part of how you work and is not seen as a burden. If your QMS has been tailored to your specific product and commercialization goals, then regulatory and standards compliance happens on a day-to-day basis instead of at the end of the product development.

Finally, remember that your QMS is a living system so it should be constantly tweaked to continue supporting you and your activities.

I invite our readers to contact me at regulations@arrowfast.tech if they have any questions or if they need help setting up their QMS.

ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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