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Antonio Bartolozzi

AAMI CR510:2021 - Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

AAMI CR510:2021 - Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices

This guide is a must read. Indispensable for all manufacturers to be guided in the use of the Cloud in collaboration with a medical device. It is also very interesting for clinical engineers. It's well done. We will comment on it in future posts. The guide contains 6

Ai Standards

Ai Standards

Ai Standards

Ai Standards

Security Standards

Security Standards

MDCG 2019-11 Step 3

MDCG 2019-11 Step 3

WARNING : In my opinion step 3 of the MDCG 291-11 has a double mistake. One mistake is typographical : lossless compression is missing in the chart. The second one is a more serious conceptual error. Recital 19 of the MDR states: "It is necessary to clarify that software in its

Medical Device Use

Medical Device Use & Intended Use

What is the “Intended Use” of a medical device? Intended use is a part of the Normal Use. The intended use includes some Use Errors and the correct use. No manufacturer is required to create a fool-proof product: it does not include Unreasonable or unforeseeable misuse. The correct use includes

Coming soon

Coming soon

This is Medical Device Software Lab, a brand new site by Antonio Bartolozzi that's just getting started. Things will be up and running here shortly, but you can subscribe in the meantime if you'd like to stay up to date and receive emails when new content