BSI establishes new regulatory team: Software as a Medical Device (SaMD)

[Contenuto in lingua inglese]

BSI has unveiled a strategic initiative aimed at enhancing its approach to Software as a Medical Device (SaMD) and SaMD with Artificial Intelligence (AI). This move underscores BSI's commitment to fostering innovation while maintaining the highest standards of quality and compliance in the healthcare industry.

Effective immediately, BSI has established a dedicated team focused on SaMD and SaMD with AI, led by Thomas Doerge as Global Head.

The decision to create a dedicated team for SaMD comes at a time when the healthcare industry is witnessing a surge in software-based medical solutions. By consolidating expertise and resources in this area, BSI aims to streamline its approach, ensuring the delivery of safer, high-quality products to a broader client base in a faster and more efficient manner.

The advantages of this strategic move are manifold. SaMD represents the future of healthcare, offering scalable and continuous software development to meet evolving regulatory requirements. By establishing a dedicated team for SaMD applications, BSI aims to stay well ahead in a competitive landscape, marked by the emergence of new regulatory bodies focusing exclusively on software.

Moreover, the creation of a focused SaMD entity within BSI reaffirms the organization's commitment to innovation and market leadership. By differentiating itself in the SaMD domain, BSI sets new standards for quality and compliance, positioning itself as a regulatory industry leader in healthcare technology.

The new SaMD will be lead by BSI's Thomas Doerge. Resources across BSI will be drawn into the team based on demand for SaMD work, ensuring efficient resource allocation and short lead times in response to growing demand.

Global Head SaMD, Thomas Doerge, said: "The creation of this new team shows again that all of us at BSI remain committed to innovation. By creating a dedicated team we are able to set new standards for quality and compliance and position ourselves as a regulatory industry leader in healthcare technology."

As BSI positions itself for long-term success, the establishment of a dedicated team for SaMD promotes innovation, whilst maintaining compliance amongst its clients in the healthcare technology sector, ultimately contributing to a healthier and more connected world.

For further details and inquiries, please contact BSI directly.