Great demands were put on usability and ergonomically correct use. Therefore, users and other stakeholders were involved in the development. Adapting the design to the current process competencies in Ambu’s plant in China was also an important issue, as the items are disposable meaning that low unit costs was an important focus area.
Since early 2004, Technolution has worked with Ambu on the development of training and resuscitation equipment to hospitals and rescue services. We have been responsible for the entire project, from definition of concept, design, usability studies, construction, materials, documentation and manufacturing of tools and validation of the production line.
We worked according to Ambu’s development manual and contributed with our skills to develop medical articles for regulatory requirements, including the CE marking for the Medical Device Directive and FDA approval 510 (k). The production took place at Ambu’s plant in China where we have visited on a regular basis to participate in the production start-up and to undertake all approvals of the prototype, O-series etc.
A unique product family was created counting a total of 15 variants in 7 different sizes covering premature babies and upwards.
The design is revolutionary as complies with the following:
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