5. Safety assurance: certification
The purpose of certification is to provide a customer with a guarantee that a product conforms to its specification, particularly in terms of safety. In our case, safety specifications are at the heart of the matter. This certification is generally issued by a third-party organization such as G-MED in the medical field, which has been focusing on medical robots for some years now. This section summarizes how medical robotics systems deal with certification.
Although risk analysis alone is not enough to obtain certification, it nevertheless forms the core of today's main certification requirements. To harmonize and ensure a high level of safety, three European directives,
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Safety assurance: certification