We are proud to announce that Seerlinq is now certified as a Class II(b) medical device according to the EU MDR 2017/745 regulation. This major milestone confirms that our products meet the highest standards in risk management, clinical evaluation, and technical performance.
In addition, we have obtained the ISO 13485 certification, the internationally recognized standard for quality management systems for medical devices. This certification not only ensures that our processes are optimized for safety and efficiency but also serves as a foundation for MDSAP (Medical Device Single Audit Program), opening doors to broader international markets.
For our customers and partners, this means an even higher level of reliability and quality when using our innovative solutions.
We thank everyone who contributed to achieving this success. We continue our mission to deliver cutting-edge medical technologies with a focus on safety and effectiveness!