Antonio Bartolozzi
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
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