28.6.2024 | Marginum News

Marginum quality management system ISO 13485:2016 certified

Kuva 6E6A8238
Figure 1. Marginum HIVEN device

Marginum introduces a pioneering, precise tumour detection system, establishing an entirely new branch in intraoperative tissue monitoring seamlessly integrated into existing surgical workflows. HIVENTM targets glioma operations to improve the quality and workflow of fluorescence-guided surgeries.

The quality management system of Marginum Ltd has been assessed and certified as meeting the requirements of ISO 13485:2016 and EN ISO 13485:2016 for design, development, manufacturing and sales of medical devices intended for optical tissue monitoring used in fluorescence-guided surgery.

“The quality management system is not only a regulatory requirement, but also guides our everyday work to ensure continuous improvement of processes and products across their life cycles. Quality goes beyond compliance”, notes Marginum CTO Juho Leskinen.
Marginum QMS Certificate
Figure 2. Quality management system certificate ISO 13485: 2016.
“Acquiring the ISO 13485 certification for our quality management system is a significant milestone. Safety and quality are non-negotiable in the medical device industry, and companies need to ensure best practices in everything they do. We are grateful for the close collaboration with Centres of Excellence and will continue our efforts to obtain CE certification for HIVEN, our first product”, says Marginum CEO Samu Lehtonen.

Marginum is developing a fluorescence-based tissue monitoring device that enables quantitative tumour margin detection and constant real-time feedback of fluorescence. Thanks to customised software and a 360-degree “black box” inside the device – an optic sector that normalises light reflectance and absorbance to ensure a standardised optic environment, all resected tissue is analysed objectively when flowing through the HIVENTM device. Improved decision-making and surgical performance are expected to lead to the best possible treatment outcome in terms of preserving functionality and resecting tumour margins.

Additional information:

Samu Lehtonen
CEO, Marginum Ltd
samu.lehtonen@marginum.com
+358 40 579 7890

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