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 affect the safety or effectiveness of the device". ...

considering the immediate risks of both acupuncture and transcutaneous electrical nerve stimulation are well documented and are minimal when performed by an experienced practitioner, and electroacupun...

Often times with group projects information is delayed because everyone works on a different schedule. at my current job, our in person meetings are organized, however are not given a time limit to e...

In my experience, NDAs have been sufficient in protecting ideas during development. patents, even provisional ones must include every detail of the device. if the device is still in development, you...

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 is still covered by the agreement. I believe in th...

@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 procedure rather than exchange goods. in the case...

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 will likely be handled with acceptance or transfere...

I mentioned in the Risk management meeting thread of a system to follow when brainstorming for potential risks During the brainstorming process identifying risks, priority should be placed on the risk...

while many have mentioned FMECA as the main tool for identifying risk, I believe during the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of...

China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in ma...

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 effects of the activity on the subjects rather than the...

With any clinical trial, the ownership of the intellectual property will be established in the contracts between both employer and employee and between the sponsor and any contracted assistance. I th...

I can understand clinical experience being desired for an investigator, however research experience and good communication/people skills seem to be more important. While clinical experience icludes p...

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