It's official:
From their website
Amsterdam, November 4, 2024 – We are thrilled to announce that Nicolab has achieved compliance with both the EU Medical Device Regulation (EU MDR) and the UK Medical Device Regulation (UK MDR). This important milestone highlights our commitment to delivering safe and effective healthcare technology.
The EU MDR and UK MDR are stringent regulatory frameworks designed to ensure the safety, quality, and performance of medical devices. Compliance with these regulations is essential for bringing innovative healthcare solutions to the European and UK markets.
Achieving MDR compliance confirms that Nicolab’s StrokeViewer meets rigorous criteria for safety, performance, and reliability. Our solution for stroke diagnosis and management is trusted by healthcare professionals. With comprehensive risk management, clinical evaluations, and quality assurance, Nicolab ensures that StrokeViewer delivers consistent, accurate, and reliable results. Our EU and UKCA certificates guarantee high-quality performance, empowering healthcare professionals with quick and reliable access to vital information.
With MDR compliance secured, Nicolab is ready to expand its reach and continue innovating in the field of medical imaging. This achievement lays the foundation for future advancements and collaborations.
