Our Certificates
High Quality & Data Security
Responsibility obliges. As a medical device manufacturer, we create digital solutions for patients in accordance with internationally recognized standards and regulatory requirements.
System Certificates
Our management systems are certified according to ISO 13485 and ISO 27001 standards. They represent our clear commitment to quality management in line with regulatory requirements as well as to protecting data through a security concept with ongoing adaptation to new risks. Compliance with these standards is verified annually by external accredited certification bodies.
ISO 27001
Information Security
Certified ISMS for cyber and information security as well as comprehensive protection of data and IT systems.
Certificate No.
12 310 63813 TMS
Certification Body
TÜV SÜD Management Service GmbH
ISO 13485
Quality Management
Certified QMS for verified processes, controlled risks, and reliable product quality.
Certificate No.
Q5 124950 0002
Certification Body
TÜV SÜD Product Service GmbH