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As a long time med tech participant I'm always interested in solutions that prick our collective sense of importance to the universe. This summary of data on exercise as an offset to the progression of Alzheimer's really blew me away. Billions being ...
source: https://www.linkedin.com/groups/78665/78665-6032178835502485505
We discussed the 21st Century Cures Act last week at and linked to a US Energy and Commerce Committee (ECC) paper which included this passage: "In a perfect world, R&D dollars would flow toward the areas of highest need where the severity or burden o...
You receive parts from a supplier. If those parts are made into subassembly at your location, you classify them as such. When the part is made at the supplier, it could one part or a subassembly. How do you classify as such into your system?source: h...
Those who have launched a medical device, how did you develop the executable software? Any experiences with purchasing software vs in house development or other methods is appreciated. source: https://www.linkedin.com/groups/78665/78665-6030128815324...
The DIS2 of the ISO 13485 now and projected for the release in end 2015.Why not scrap this project, let the ISOTC210 take due time and come up with the ISO 13485: 201x aligned to the ISO 9001: 2015 on the lines of the HLS.Any standard must standardiz...
Good or bad? The US House-approved "21st Century Cures Act" (now on its way to the Senate) tries to reduce the costs of bringing treatments to the patients that need them. Here's a link to the short US Energy and Commerce Committee paper which recomm...
Thoughts - A device such as ultrasound device, whose life span is 5 years. In its 6th year device does not work properly. The customer calls the manufacturer. The manufacturer offers to repair the device even though the device is outside its lifespan...
Billing itself as "the world's first maskless, hoseless, cordless, micro-CPAP device," startup Airing made a stir with its crowdfunding campaign this month, raising $800,000+ and attracting 4,000+ patients hoping to try the product as early as July 2...