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MDCG 2019-16 Part 2
MDCG 2019-16 - Checklist
APP for the prevention of STIs (sexually transmitted diseases)
BAD NEWS : segregation is mandatory for all classes, not just for class C medical device software
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