Our Certifications
Learn more about the certifications and standards supporting the quality and compliance of our medical devices.
Compliance with Regulation (EU) 2017/745 on medical devices
The U-Care Renal Platform is CE-marked 0425 Class IIb medical device software under Regulation (EU) 2017/745 on medical devices (MDR).
Developed by U-Care Medical, the platform undergoes conformity assessment against the applicable general safety and performance requirements set out in the MDR.
ISO 13485:2016 Certification
U-Care Medical operates an ISO 13485:2016 certified quality management system, based on a standard specifically developed for organisations in the medical device sector.
The U-Care Renal Platform is developed through structured quality assurance and control processes that follow the applicable requirements of the standard.
GDPR compliant
U-Care Medical implements technical and organisational measures to process personal data in accordance with the applicable requirements of the GDPR.
Data protection and information security are considered from the earliest stages of the platform’s design.
Personal data are processed in accordance with European legislation and the measures set out in the relevant privacy documentation.