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Antonio Bartolozzi

BAD NEWS : segregation is mandatory for all classes, not just for class C medical device software

BAD NEWS : segregation is mandatory for all classes, not just for class C medical device software

Antonio Bartolozzi Nov 13, 2023
Usability & GSPR4 : What is the impact on safety?

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
Antonio Bartolozzi Nov 8, 2023
Intrinsically safe SaMD design

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
Antonio Bartolozzi Nov 7, 2023
AFib History Feature vs IFU

AFib History Feature vs IFU

Antonio Bartolozzi Nov 4, 2023
Apple vs Medical Device  2 : The Revenge.

Apple vs Medical Device 2 : The Revenge.

Antonio Bartolozzi Nov 1, 2023
Apple Watch & Apple ECG App. Cupertino, we have a problem.

Apple Watch & Apple ECG App. Cupertino, we have a problem.

Antonio Bartolozzi Oct 29, 2023
MDCG 2023-4 What are the effects?

MDCG 2023-4 What are the effects?

Antonio Bartolozzi Oct 24, 2023

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