When I first started at Sloan Kettering, I worked in the contracts unit which handled agreements including NDAs. Usually contracts units use in-house ...
I used to work in the contracts group at Sloan Kettering and we would execute over 300 NDAs a year. As advice, I would say don't be afraid to negotiat...
As many have mentioned there is a big difference between an NDA and a patent. An NDA allows two parties to discuss confidential information. In indust...
I agree with @gaberuiz13 that the organizational structure can lead to different company cultures and those in turn can have an affect on projects. Th...
I agree with @hm243 that its healthy to have a some competition, but if becomes negative competition that could be detrimental to the company. I work ...
I currently work in a functional organization where as @aaq2 mentions, the functional head has a lot of power and make the decisions. As mentioned in ...
I agree that #4 "Risk management is not a lifecycle process" and that it is a mistake to think that once the development process is completed that the...
One Factor is Disease chronicity as described in "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and...
As many have stated ISO 14971 is the major ISO regulation governing Risk Management.I agree with @thuytienleco that the major phases include: risk an...
I agree with comments above that verification is important to ensure that all specifications originally laid out in the inputs are implemented correc...
As mentioned in the slides a Verification Protocol consist of: Taking all the outputs, making a test for each one, and listing all the tests in a docu...
Trouble adding link to comments: nishithdesai /fileadmin/user_upload/pdfs/Research_Papers/The_Indian_Medical_Device_Industry
I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it's intended use. I like...
In learning more on the FDA website about design controls, I found the International Medical Device Regulators Forum, which is a global approach to mo...
It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document w...