Question
This topic was submitted to my suggestion box from a colleague in Australia. For brevity sake, I’ll limit my comments here to ISO certification body auditors and exclude FDA inspectors. The basic approach is the same, but there are some important nua...
That's how much Triple-S Management Corp will pay for insufficiently protecting health information. See for what Health & Human Services said. It's not as though these rules just appeared. Group member and privacy expert Rebecca Herold writes, "Expec...
Ultrasound is still underutilized. Key players are moving toward “point of care”, that meet the rising request for more customized and easy-to-use devices. The request is for: smarter devices, portable devices, specialized solutions, connectivity, mo...
source: https://www.linkedin.com/groups/78665/78665-6076464952049225729
Unique device identification (UDI) expert, ReedTech's Gary Saner, has your answer key. ReedTech has processed more than 100,000 UDI applications for Class III devices and Class II implants, life-sustaining, and life-supporting devices marketed in the...
A UK trial has been approved to examine the use of specially trained dogs to detect prostate cancer. Does this technically make them medical devices? Is it the dogs or the training regimes that should be regulated - or both?source: https://www.linked...
I was interested in chatting with folks in the implanted device space and love to get your perspectives, please PM me if you'd like to discuss and share your perspectives, Thanks!source: https://www.linkedin.com/groups/78665/78665-6074671781375991808
This year, 280 members of Congress have voted to repeal the medical device tax. In a non-binding vote, 79 Senators have indicated that they want this tax to be repealed.Congressional action on the repeal of the medical device tax legislation is vital...
I have been researching online for some information regarding clean rooms. I do perform some work on what I think is a ISO class 7 or less. Linear flow, HEPA filter etc.What I wonder, is what is a "ISO Class 9", considering that air conditions are eq...
At last week's annual Exponential Medicine program from Singularity University, futurist and Google Director of Engineering Ray Kurzweil said, "I'm developing these neocortical models. We don't perfectly know how the neocortex works but we have enoug...
