I was president of the IET for 2016-17, and have been asked by government to gather practical and innovative ideas from our Engineering communities. So, please enter any ideas you might have in this thread that might help address and mitigate the Covid-19 crisis. Ideas might include digital tracking / monitoring through therapy equipment and beyond. Even ideas outside your usual expertise domain will be welcome. Now’s the time for Engineering to show we can change the world!
The MHRA has published guidance here which includes the specification for rapidly manufactured ventilator systems mentioned above; most of the standards quoted are ISO or IEC.
This page also helpfully advised (last time that I looked) that the British Standards Institution have made their standards on ventilators accessible free of charge.
If you need guidance on Good Manufacturing Practice for medical devices, the ISPE is the place to look - at www.ispe.org.
I can't see a GAMP Guide for embedded systems (such as a controller for a ventilator) so the general GAMP 5 Guide should apply. In cases of difficulty, PM me.
There's also a guide on Good Engineering Practice in the pharma/medical device space, and one on single use technology.
The MHRA has published guidance here which includes the specification for rapidly manufactured ventilator systems mentioned above; most of the standards quoted are ISO or IEC.
This page also helpfully advised (last time that I looked) that the British Standards Institution have made their standards on ventilators accessible free of charge.
If you need guidance on Good Manufacturing Practice for medical devices, the ISPE is the place to look - at www.ispe.org.
I can't see a GAMP Guide for embedded systems (such as a controller for a ventilator) so the general GAMP 5 Guide should apply. In cases of difficulty, PM me.
There's also a guide on Good Engineering Practice in the pharma/medical device space, and one on single use technology.
