Standards and integrations
We at Stretch Care are team players aiming to be a leader in integrating international and national standards, as well as collaborating with the best suppliers in the industry.
Here you can see a selection of the integrations and standards built into Amni Board.
ISO 13485
Stretch Care is certified ISO 13485. We are certified by TÜV SÜD.
We have a quality system specially designed for medical devices. The quality system focuses on patient safety, risk management, cybersecurity, lifecycle management, development standards, usability, and much more.
Our ISO 13485 includes around 40 other related standards and guidelines, including:
- ISO 14971
Risk management for medical devices - ISO 62366-1
Usability for medical devices - IEC 62304
Lifecycle management for medical device software - IEC 82304-1
Product safety for health software
ISO 27001
Stretch Care are certified ISO 27001, the standard for information- and cybersecurity. We are certified by Intertek.
We have developed our own information security management system (ISMS), integrated with our main quality management system. This ensures that information security and cyber security becomes an integral part of our daily work.