FHI Tech Stories: BSI Group on market developments in medical electronics

BSI Group has been an international leader in standardisation for businesses since 1901. The multinational employs approximately 5,250 people and is divided into four divisions: BSI British Standards, Assurance, Automotive & Aerospace, Consulting & Regulatory Services. BSI Group operates in 193 countries worldwide, making it one of the largest certification bodies in the world.

For this edition of FHI Tech Stories we speak with Ingeborg Knol and Marjolein van Diest of BSI Group Netherlands. BSI recently became a member of the Industrial Electronics branch of FHI.

“Basically, BSI is all about safety and quality. We help develop standards and norms and also perform inspections. The ultimate goal is to minimize risk and maximize effectiveness,” says business development manager Ingeborg.

Together with her colleague, marketeer Marjolein, Ingeborg is involved in legislation and standards around medical electronics. Both see four remarkable trends within the sector.

Increase in use of AI
Marjolein: “It is being used more and more often artificial intelligence (AI) to predict certain behaviors. This is pleasant for the patient and the practitioner because it allows them to work more effectively. At the same time, it raises ethical questions. What is medically possible is not always desirable. The AI act that was recently adopted by the European Parliament aims to provide clarity on this. This regulation determines at European level how you may and may not use artificial intelligence.”

Sustainability and ISO 14001
Another hot topic sustainability is a key issue in the sector. Companies strive to achieve ISO 14001 certification, but do not always know how to approach this in practice. Ingeborg: “Improving patient care goes hand in hand with sustainability and care for future generations. We explain what the certification entails, but we are not consultants. Ultimately, companies are themselves responsible for achieving the environmental management standards.” Ingeborg and Marjolein are happy to set a good example. “At BSI, we also roll up our sleeves ourselves, for example by cleaning up plastic waste and cigarette butts together with the entire team for a day or by organizing campaigns for the food and clothing bank.”

Smart software and the notified body
Software is a third theme that is high on the medical electronics agenda. Marjolein: “Many people do not realize that technology also has a 'soft' side. People's quality of life increases by using technology intelligently. Take a mammogram, for example. For many women, this is an unpleasant experience. If you can achieve this examination to be less painful by means of improved equipment, then you prevent human suffering.”

To ensure that medical equipment is safe to use, strict requirements have been established that are tested by a notified body: an institution that approves medical devices before they are placed on the market. It does this on behalf of an EU member state that has been designated by the government. BSI Group is also a notified body, Ingeborg explains. “An important part of our work is to explain what a notified body does exactly and how it assesses products. We notice that many companies do not understand this well. Ultimately, it is up to the manufacturer to determine how he will implement these legal provisions.”

Digital security
In addition to the substantive and technical conditions and rules, the notified body also rules on digital security. Electronics can be hacked and companies are required to take adequate measures against this. Marjolein: “With the increase in the complexity of electronics, the attention for cybersecurity is also increasing. The last thing you want, as a company and as a society, is for cybercriminals to gain influence on medical equipment. That is why strict standards and rules have been drawn up in ISO 27001, an international standard for information security.”

Many questions
That certification of electronics raises many questions was evident from the crowds at the BSI stand at the Medical Electronics event on 6 February in Vianen. Ingeborg: “We did not expect to get so many visitors. People mainly had questions about ISO certification, product testing (IEC 60601) and CE markings. The hardware and software that manufacturers use are becoming increasingly sophisticated and so the requirements before the product is allowed on the market are also increasing.”  

More involvement 
BSI Group is proud to be part of the FHI network. “The association offers us a new channel to share knowledge,” says Marjolein. “Collaboration is already an important part of our work and it will only become more important in the future. Our goal is to create more involvement between the different stakeholders. We do this by participating in trade fairs, events and workshops and by organizing training courses and webinars. We want to spread as much knowledge as possible in order to contribute to a safer world.”

Meet BSI
BSI Group will be present at the Medical Electronics event and the E&A fair.
Would you like to know what BSI Group can do for your company or are you interested in collaborating with this new member? You can find more information on the website.