
13/06/2025
BRAEBON Achieves EC MDR Certification for MediByte & MediByte Jr
BRAEBON Medical Corporation is proud to announce a significant milestone in our ongoing commitment to quality, compliance, and patient safety.
BRAEBON has officially obtained the EU MDR Quality Management System Certificate for MediByte, MediByte Jr, and the MediByte software!
This certification confirms that our quality management system and technical documentation have undergone a thorough conformity assessment and meet the high standards set forth by the EU Medical Device Regulation (MDR).
As a result of this achievement, BRAEBON is now authorized to apply the CE 2862 marking to our certified medical devices — a clear indicator of our adherence to European regulatory requirements and our dedication to product safety and performance.
What This Means for You:
1. Stronger regulatory assurance across the EU market
2. Greater confidence in the safety and efficacy of BRAEBON recorders and software
3. Uninterrupted access to CE-marked products for your patients and customers
This is more than just a certification—it's a reflection of our commitment to providing quality medical devices that improve patient care and consistently meet regulatory and customer requirements through an effective and maintained Quality Management System.
Thank you for your continued trust and support!