Question
Is anyone aware of the FDA guidance documents to say what medical devices require specialized instructions for disposal? I’m not talking about ones with obvious hazards such as implantables or ones with sharps, but simple Class I single-use devices. ...
As originally asked by
I’m currently a student at the University of North Carolina at Chapel Hill, studying economics. I am taking an Entrepreneurship class, where we must create a venture in relation to health care.My group has come up with an idea to create wristbands th...
Is it mandatory to have GS1 GTIN barcoding on medical device? I understand US FDA has made UDI mandatory, but for a company which is not targeting US market is it good to have a GS1 GTIN barcoding in place. source: https://www.linkedin.com/groups/786...
source: https://www.linkedin.com/groups/2526855/2526855-5905909540020310019
If you make the selection just on cost, in about a year, you may be very sorry about the decision you made, began Mark Rutkiewicz, VP, Quality at Innovize. His was a really solid talk. I'll share the first of his five questions here. You can find the...
There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.Let’s say I am designing a PCB and have to write a protocol to test ...
As originally asked by Joe Braido. If anyone can reference a good contract manufacturer to pouch and final pack simple devices in a quick turn around, please contact me. James Wisser President at Pinehurst Plastics Robling Medical - Brent Robling is ...
That's a fancy health tracker on your wrist. Is it medically accurate? Tracking devices – monitors, if you will – have been around for a long time. In the intensive care unit, the patient is monitored 24 hours. Your fitness tracking device may not ev...
I'm looking for a good industry conference on the "geekier" side of med device development--design controls, quality systems, FDA regulations, user need assessment, etc. Has anyone attended an industry meeting on these topics that was useful and stim...
