Compliance to regulatory standards is a key part of any design for medical devices. In fact the impetus for writing this whitepaper was a fear that well-meaning but biomedically naive groups combined with eased regulatory standards and Covid-19 frenzy could lead to dangerous devices ending up in the hands of desperate clinicians. No framework for evaluating newly created devices in something like a pandemic has ever been created.
For exactly the reason you mention, we are urging caution.
There are many groups looking for compliance consultants right now. Know any?
Yes, it was reassuring to see that a major consideration (and priority) of this project is the safety of devices to be produced amid the pressure there is to produce them en masse so quickly!
I do, in fact, know someone with safety inspection background and a desire to contribute to both stopping the spread and providing for those affected. Please feel free to contact me to connect you to each other. #inthistogether
Compliance to regulatory standards is a key part of any design for medical devices. In fact the impetus for writing this whitepaper was a fear that well-meaning but biomedically naive groups combined with eased regulatory standards and Covid-19 frenzy could lead to dangerous devices ending up in the hands of desperate clinicians. No framework for evaluating newly created devices in something like a pandemic has ever been created.
For exactly the reason you mention, we are urging caution.
There are many groups looking for compliance consultants right now. Know any?
Yes, it was reassuring to see that a major consideration (and priority) of this project is the safety of devices to be produced amid the pressure there is to produce them en masse so quickly!
I do, in fact, know someone with safety inspection background and a desire to contribute to both stopping the spread and providing for those affected. Please feel free to contact me to connect you to each other. #inthistogether
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