Product governance

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.

Quality

Meeting and upholding quality standards in our systems, processes and products is our license to operate as a medical device manufacturer. Ambu’s global quality management system is structured around procedures and processes that cover all aspects of Ambu’s operations – from management responsibilities, design control, risk management, process and production controls to product surveillance and more.

Animal- & clinical trials

Animal testing and clinical trials for clinical investigations are in some situations, and in certain countries, required during research and development to demonstrate the safety and effectiveness of the product as part of the regulatory authorization process or to further substantiate the performance of the product in a real-world setting.
When animal testing is required, we follow all applicable laws and regulations. We follow the ‘Triple R’ principles. All clinical trials must be conducted in accordance with ISO 14155 Clinical investigation of medical devices for human subjects, GCP and DOH and local regulation.

 

Cyber security

Ambu is widely dependent on the availability of reliable and trustworthy information and the efficient use of information systems. Prevention of unauthorized access to information and information systems and unauthorized usage or corruption of information and data is therefore of vital importance to Ambu. Therefore, Ambu continuously implements measures and controls to minimize the risks in order to respond to the evolving threats.

Certifications

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

Read our latest sustainability report

Download our latest sustainability report for more insight on our sustainability approach and initiatives.

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Find sustainability reports from previous years here

 

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