Question
Hello everyone, I am evaluating the incorporation of remote data logging and network (likely wireless) connectivity for a class II and potentially class III device. Could anyone point me in the direction of any 510k cleared predicate devices that I m...
I'm largely ignorant of how Class I devices get on the market and then what happens next. I typically work with Class III, and sometimes Class II. However, I've started running into early-phase start-ups with a basic technology that could be develope...
Do you believe it's worthwhile to market a medical device used in surgery directly to patients? I don't. To be clear, I'm not talking about durable medical equipment (wheelchairs, diabetic supplies). I'm talking about devices that "improve patient ou...
One issue I always had during my career was the unknown condition of equipment that had been used around patients and possible exposed to bodily fluids. I was worried about whether they could present a bio-hazard to repair and indeed the entire organ...
Anyone purchased medical devices from China? What is your opinion and sugestion? Thanks.source: https://www.linkedin.com/groups/78665/78665-6162349654370512899
source: https://www.linkedin.com/groups/78665/78665-6160856893351874560
Hello everyone. I am looking for a medical device to measure trans-diaphragmatic pressure. We know this can be done by combining the measurements of abdominal pressure measured with a gastric catheter, and pleural pressure, as assessed with an esopha...
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If you had to give someone designing a medical device just one tip, what would it be?As a marketeer mine would be: 'Start with the customer and work backwards.'Note: I'm hoping to use some of these comments in an article I'm writing, full credit will...
Life science companies have paid multi-billion-dollar fines resulting from non-compliant promotion. FDA requires companies to have a system in place to ensure that their promotions meet FDA expectations. Big device companies have an internal Promotio...
