Quality and Compliance: The Foundation of RetInSight’s Success
In the dynamic environment of high-end device development at RetInSight, quality and regulatory compliance are far more than mere checkboxes – they are the very foundation of our credibility and the driving force behind our market success.
These principles are a testament to our company’s culture and leadership values, which we integrate into all areas of our business and operations.
Our medical software fulfills highest quality and regulatory compliance standards: GDPR, HIPAA, GCP, MDR 2017/745, ISO 13485, ISO 27001.
EU Quality Management System Certificate MDR
RetInSight has meticulously established, documented and implemented a state-of-the-art Quality Management System, fully aligned with MDR (Regulation 2017/745 on Medical devices, Annex IX, Chapters I and III).
ISO 13485 Certification
RetInSight has successfully implemented all ISO 13485:2016 requirements, certifying our commitment to producing safe, reliable and effective medical devices that adhere to the internationally recognized gold standard of the medical device industry.
ISO 27001 Certification
RetInSight is deeply commited to safeguarding the confidentiality, integrity and availability of information and data. As an ISO 27001:2022 certified company, we ensure the seamless integration of the Information Security Management System framework into our processes.