Quality is not an act, it is a habit, the Greek philosopher Aristoteles once said. Still, today, these words are true and highly relevant also in the medical device industry. Being capable of developing and manufacturing high-quality medical devices doesn’t happen overnight. It takes years of knowledge, experience, and practice. I had a chat with Sofia Andersson, Quality Engineer at Elos Medtech, Skara in Sweden, about quality and validation in the medical device industry. 

Hi Sofia, what do you do as a Quality Engineer at Elos Medtech? 

In my role as a Quality Engineer, my main mission is to ensure that our quality and environmental management system is robust and effective by continuous inspection, evaluation, and development. Compliance with applicable standards, and regulatory and customer requirements, is examined through external and internal audits which I both participate in and perform. I work with interpreting and understanding these requirements, transforming them into procedures and instructions, and training other employees in them. Risk management, validation, and handling of nonconformities and complaints are also essential parts of what I do. 

When I started working at Elos Medtech about six years ago, my role was much wider. But over the years, the company has grown and taken on new exciting projects, which has made my role more focused on specific areas. It has been inspiring to be part of the transformation towards becoming a more specialized development and manufacturing partner for global medtech companies. 

Do you work on any especially exciting projects at the moment? 

Yes, right now, I am involved in a cleanroom production project. As more medtech companies are looking to outsource cleanroom production of medical devices, we are expanding our production site in Skara by doubling the production area. Achieving a  cleanroom environment that meets both customer requirements and ISO standards places great demands on the quality of rooms, equipment, materials, personnel, and practices. 

How would you describe good quality in the medical device industry? 

A short description of good quality in the medical device industry would be meeting the requirements and expectations that ensure product safety and function. At Elos Medtech, we always aim to achieve the highest quality – by not doing too little and not doing too much – but doing exactly the right things. This generates good quality. 

What is the greatest challenge working with quality and validation? 

As a CDMO, it can sometimes be challenging to ensure that the customers’ expectations are translated into procedures and instructions in a way that leaves no room for interpretation and that creates an understanding of what is process and product critical. At Elos Medtech, our commitment is never to compromise on quality, safety, and compliance. This step is therefore very important in creating engagement and giving the right prerequisites to achieve our quality objectives and be empowered to take action to protect patients and customers. 

Covid-19 turned the entire world upside down. Working with quality at Elos Medtech, what challenges have you faced during the past year? 

Like many others, we have worked more from home and have had to learn new ways of communicating with customers and doing things remotely. But that is a positive learning experience, which I think can be very useful for the future.

As the pandemic spread rapidly worldwide, so did the need for treating Covid patients in intensive care units. As a CDMO of essential components used for the treatment of Covid patients, we were asked to increase our production several-fold. Although it has been challenging, quality departments usually play a key role in solving issues when they arise, and last year was no exception. But this is also what makes the job so much fun – no two days are alike.

“As a CDMO of essential components used for the treatment of Covid patients, we were asked to increase our production several-fold.”

We also did a re-certification of our ISO 13485. To maintain your certification, you need to pass a re-certification audit once every three years. This had to be done remotely, which was a little different from what we are used to, but it went very well. In the near future, I will also need to handle supplier audits remotely, which will be a challenge as it is easier to get a grip of a situation when you can be there in person and see things for yourself instead of just listening to a description and look at documented evidence.

What is required to ensure high quality in the medical device industry? 

This is a very complex question to answer as it is a combination of many factors – being capable of developing and manufacturing high-quality medical devices does not happen overnight. It takes knowledge, experience, capacity, and a robust management system that is well-rooted in the organization. I also believe that an important factor as a CDMO is to be flexible – both in your ability to handle changes and in the setup of your management system – so that you can quickly adapt to new or changed requirements. But above all, you need to understand and be responsive to both the stated and unspoken needs of the customer and share your knowledge to provide the best support and solutions. 

Thank you, Sofia, for sharing your insights into the medical device industry and your experience as a Quality Engineer at Elos Medtech!

Are you looking for a global development and manufacturing partner for medical devices? Visit Elos Medtech’s website to learn more about our offering.