Suturion is ISO 13485 certified – a major milestone on our journey

Suturion has achieved ISO 13485 certification – an internationally recognized standard for quality management systems in the medical device industry. This certification confirms that our processes, systems, and procedures meet rigorous global requirements for design, development, production, and delivery of medical devices.

Achieving ISO 13485 is more than a stamp of approval — it is a key enabler of our continued growth. It paves the way for entering new markets, scaling manufacturing, forming strategic partnerships, and ultimately delivering our innovative solution, SutureTOOL™, to even more surgeons and hospitals around the world.

This milestone reflects our deep commitment to quality, patient safety, and continuous improvement. It has been made possible thanks to the hard work and dedication of our incredible team, who have worked diligently to integrate quality into every aspect of our organization.

As we take this step forward, we remain focused on our mission: helping reduce complications after open abdominal surgery by making the small-bites technique more efficient, safe, and accessible.