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            Usability & GSPR4 : What is the impact on safety?
Usability vs safety. Plane crashes are instructive for understanding how safety depends on technical choices. A Saab 2000 risked crashing in 2014 despite not having the slightest problem. After being struck by lightning (which did not damage the plane in the slightest, as almost always happens), the pilots wanted to
            
         
            Intrinsically safe SaMD design
GSPR 17.1 and 18.1 pose a notable challenge to the designer: “in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks”.
How do you design a device that complies with these two requirements? It will
            
         
            AFib History Feature vs IFU
 
            Apple vs Medical Device 2 : The Revenge.
 
            Apple Watch & Apple ECG App. Cupertino, we have a problem.
 
            