Antonio Bartolozzi
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
Security Standards
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 & 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