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SNV Story No. 3: committed to international standardization with her heart and soul
Profile of Eliane Galbussera, standards expert and quality manager
Eliane Galbussera studied chemistry (University of Applied Sciences) and is now the business owner of Quality & Care GmbH. For more than 20 years, the professional life of management consultant Eliane Galbussera has revolved around standards and regulations in one way or another. In 2019 she joined the INB/ SC 410 «Quality management and corresponding general aspects for medical devices» as a standards expert. Here is her story, which reveals the career path of a thoroughbred expert.
Image caption: The standards expert Eliane Galbussera visits the SNV in Winterthur
Standards trigger a sense of curiosity
After completing her studies in chemistry, Eliane Galbussera was responsible for the introduction of a QMS in accordance with ISO 9001 at a recycling company in her position as Quality Manager. She subsequently switched to the pharmaceutical industry, before later moving to the medical industry. As she not only wanted to answer questions, but rather also pose them, she trained to become an auditor and has worked in this role for the two certification bodies Bureau Veritas Certification GmbH and Swiso GmbH since 2013. The QMS expert views standards as efficient and important instruments for an organization, as well as during the development of a product.
Her thirst for knowledge and her curiosity later led to her delving deeper into the creation and handling of standards and it is therefore almost logical that she has also been working for the SNV as an expert in the committee for INB/ SC 410 «Quality management and corresponding general aspects for medical devices» since autumn 2019.
International standards as a source of motivation
«Thanks to my membership in the national standardization committee, including for the standards SN EN ISO 13485 «Medical devices – Quality management systems – Requirements for regulatory purposes», IEC 62304 «Medical device software» and ISO 14971 «Medical devices – Application of risk management to medical devices», I am always one step ahead of developments.»
As an expert, she works on specific standards, including IEC 62366-1:2015/FDAmd «Usability» which was only voted on recently.
The experienced specialist is happy to participate in standardization work, but only if she can make an effective contribution due to the fact that she knows the standard under discussion and has already applied it. She likes to stay on the ball, contribute her specialist knowledge and is able to take a step back when others know more than her.
Eliane Galbussera puts her heart and soul into standardization work as she likes to deal actively with the associated content in a different way to the manner that she does as a user. She critically assesses the individual paragraphs and checks whether they are still in line with state-of-the-art developments or require improvement. She is convinced that you gain a better understanding of a standard if you are involved in it. And she values being able to actively shape the standard.
Introducing a medical device in the US would be impossible without standards
Before Eliane Galbussera set up her own company in 2019, she assumed responsibility for the international introduction of a medical device in her role as Director for Quality Management & Regulatory Affairs at the multi-award-winning start-up company Ava AG – a Swiss digital health company that wants to revolutionize the health of women and already has offices in Zurich, San Francisco, Makati and Belgrade. Ava AG has developed a fertility tracker that supports women with family planning and does not require hormonal medication or invasive procedures. The company was recognized at CES 2017 (CES = Consumer Electronics Show) as the Best of Baby Tech and by Women’s Health as the Editors’ Choice and was also awarded the title of the best Swiss start-up in 2017 and 2018.
As the tracker is a medical device, certain standards have to be adhered to. Thanks to a Medical Device Single Audit Program (MDSAP), Ava AG has been able to launch its product simultaneously in several markets. The QMS expert was also responsible for the fact that the company was certified in accordance with SN EN ISO 13485 «Medical devices – Quality management systems – Requirements for regulatory purposes» in 2016.
During the entire introduction process, Eliane Galbussera valued the availability of existing standards: «I believe the fertility tracker would only have been half as good without standards. Standards also place demands. You need to pass certain tests. Only then, for example, do you have the right to a certificate of conformity in Europe. A kind of distinction, the CE.»
Four questions to Eliane Galbussera – the expert in the interview
We have invited Eliane Galbussera for an interview at SNV to find out how she became a standards expert. In the following film «Norm sei Dank» she tells us that, among other things, it is very important to her to be up-to-date and to be able to influence the development of a standard. Find out more about international standardization work from the mouth of the committed expert. Unfortunately the film is only available in German.