When I first started at Sloan Kettering, I worked in the contracts unit which handled agreements including NDAs. Usually contracts units use in-house counsel to develop templates. Honestly most NDAs i...

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 negotiate a NDA. Sometimes people just see an NDA and sign...

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 industry if you have a product and you would like to dis...

I agree with @gaberuiz13 that the organizational structure can lead to different company cultures and those in turn can have an affect on projects. There are many different types of companies and proj...

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 in a functional organization structure in the lice...

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 lecture one of the main disadvantages is that we a...

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 risk management documentation ends. I agree with ...

One Factor is Disease chronicity as described in "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications" For example if a patien...

As many have stated ISO 14971 is the major ISO regulation governing Risk Management.I agree with @thuytienleco that the major phases include: risk analysis, risk evaluation, risk control, residual ri...

I agree with comments above that verification is important to ensure that all specifications originally laid out in the inputs are implemented correctly and comply with previously determined regulati...

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 document. My example of a verification test will be su...

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 @williamzembricki's comment "When in doubt, valid...

In learning more on the FDA website about design controls, I found the International Medical Device Regulators Forum, which is a global approach to monitoring the manufacturing of medical devices in o...

It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of...