Passing the eye of the needle
Before a product is used with patients, it has been through a long process as it must pass a number of tests, including product verification (laboratory testing) and validation of both product and processes as well as upscaling in production.
The product must also be approved by numerous external bodies such as the relevant certifying bodies (i.e., the US FDA / MDR authorities, country specific authorities, etc.).
To ensure the success of the external approval processes, an adequate quality management system must be in place.
Certifications
Ambu is certified according to ISO13485:2016, MDSAP, UKCA and MDR and for Medical Devices. For non-Medical Devices Ambu is certified according to ISO9001:2015.
Read about our latest sustainability efforts
Download our annual report and find out more about our sustainability strategy and initiatives in the sustainability section.