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.
Ambu is certified according to ISO 13485, MDSAP and CE for Medical devices, and ISO 9001 for non-medical devices.
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