Question
What we dilute into oblivion only makes us stronger. The strongest homeopathic medicines are diluted so far each pill has less than one molecule of the active ingredient. If only we could make this work for antibodies and cytokines. I hope sales of t...
My favorite was the artificial pancreas. Least favorite was the 360 wheeled car (not actually an invention because they have not reduced it to practice, and was probably in Popular Mechanics 50 years ago). Haven't these guys heard of CRISPR? http://t...
I was recently going through the WHO statistics for Cataract surgery rate and the data they provide is of 2003 & 04. It means either they have either not updated the stats or the figure hasn't changed in the past years. What do you guys think ???...
So, ISO 14971:2007 is officially going into a revision as deliberated in the ISO TC 210 Delft meeting today. Now the work begins!!source: https://www.linkedin.com/groups/2070960/2070960-6204883472100651009
(obviously a lot of factors go into this like sales cycle, training etc - just trying to get a straw poll) source: https://www.linkedin.com/groups/78665/78665-6205062427961360388
Will Trump's immigration policy affect medical device employment? Some general items of interest include: 1) What, if any, US job prospects via H-1 sponsorship are currently available for international Biomedical and Electrical Engineers, 2) What are...
I get a surprising number of inquiries from startups in the business of needles: Disposing of them, how to avoid getting punctured, how to make them less painful for children, and other concepts including doing away with them completely. See: Sharps ...
Chinese FDA to Update the Medical Device Classification CatalogueLate last month, the CFDA released a draft document updating their Classification Catalogue for medical devices. The currently used classification catalogue for medical device was publi...
I understand the existing requirement for updating Clinical Evaluation Reports with respect to current safety and performance information. But, I was wondering if there is also an expectation to update Clinical Evaluation Reports with the other new r...
If you have testing data for safety and performance, but the data does not meet the current requirements for a submission, what should you do?For Europe, companies are required to update their technical documentation and retest when appropriate. If t...