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Friday, 15 April 2022
By Mitch on Friday, 15 April 2022, 14:26 - Regulations
We saw in the previous post how the lifetime of a SaMD can be defined. Let's continue with the operations that can affect this lifetime.
Friday, 10 August 2012
By Mitch on Friday, 10 August 2012, 15:36 - Misc
Hi everybody,
I was out of the office, I didn'it have time to write anything relevant about our favorite subjects.
Here is an interresting article of The Economist (link will be dead after a while) about open-source software.
Seen on the newsletters I receive for vigilance, the recall of a defibrillator due to software failure: here on MHRA website and here on ANSM Website (in french).
For those who spent their vacation on Mars and haven't heard about Proteus ingestible biomedical sensor yet, have a look at this article. This is a double performance: technical with an ingestible sensor, and regulatory with clearance through the new "de novo" FDA process.
And to end with a bit of futurology, this new article of EMDT about the future of medtech.
Bye.
Thursday, 5 January 2012
By Mitch on Thursday, 5 January 2012, 19:45 - Misc
Dozens of companies recall their medical devices every month. A recall
happens when something wrong happened with the device, like a bad labeling or a
bad sterilization. It's the responsibility of the manufacturer to warn ALL
their customers and the government agencies that a given lot or batch of
products has a defect. The batches shall be destroyed or sent back to the
manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone
app used to compute a score to assess the desease of patients according to
complex algorithms. There is a bug in the app and it gives wrong results.
