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For 10 years, Dexcom made this claim: Continuous glucose monitoring (CGM) is intended to supplement, not replace, a blood glucose meter. A confirmatory finger stick is required prior to treatment. This is known as an adjunctive claim, because the mon...
As originally asked by Brian Biersach. In the past year, I’ve seen something that I haven’t seen in my whole career of medical device compliance work. Devices that don’t work (software and hardware problems), serious compliance issues with performanc...
We are prepping to manufacture Medical Sterilization Machines for surgical tools prep and post surgery sterilization, and would be interested in learning the standard that should be applied in the final design.source: https://www.linkedin.com/groups/...
Kyle Vlasak
VP Sales and Marketing at Vonco Products LLC | Job Search Coach and Author
September 2018
Polyolefins have been shown to be safe alternatives to PVC's widely reported risks.However Polyolefin films make up only a small percentage of liquid tight medical bags in the US with shapes and fitments.Is it because of the sizable investments alrea...
Hey med developers, I was thinking about all the work that goes into medical devices and how much resistance there can be to design thinking so much of the time. It has become extremely popular in consumer device design, but not so quickly accepted w...
I was talking with a client in the medical device design & development space. He and every one of his competitors claim they are ISO:13485 certified and have many experts. They boast their client roster, show their portfolio, and promise quality/spee...
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