to follow up on what was posted above, for software updates, which may seem trivial, device approval is based on if the update "could significantly af...
considering the immediate risks of both acupuncture and transcutaneous electrical nerve stimulation are well documented and are minimal when performed...
Often times with group projects information is delayed because everyone works on a different schedule. at my current job, our in person meetings are ...
In my experience, NDAs have been sufficient in protecting ideas during development. patents, even provisional ones must include every detail of the d...
In many CDAs or NDAs it will be stated that the information belongs to the disclosing party, therefore any version or permutation of the information i...
@rachel, I do not believe a guardians medical decision counts as a verbal agreement as the doctor/hospital is seeking consent to perform an emergency ...
I believe risks should be handled differently depending on how critical the part of the device the risk is associated with. the most critical parts w...
I mentioned in the Risk management meeting thread of a system to follow when brainstorming for potential risks During the brainstorming process ident...
while many have mentioned FMECA as the main tool for identifying risk, I believe during the brainstorming process identifying risks, priority should b...
China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has b...
I did my Bachelors at Long Island University, Brooklyn where I did subject based research. while devices were used, the purpose was to test the effec...
With any clinical trial, the ownership of the intellectual property will be established in the contracts between both employer and employee and betwee...
I can understand clinical experience being desired for an investigator, however research experience and good communication/people skills seem to be mo...
Fresenius Medical Care Vision Statement: "Creating a future worth living. For patients. Worldwide. Every Day." "About four decades of experience in...