Last seen: Dec 7, 2020
Due to the importance of the NDA and the terms it mandates it is important to fully understand and be in agreement with whatever you are signing. I al...
Although I agree with some of the point mentioned by you guys, but is there more information regarding the job firing? Is it due to poor performance, ...
Although I agree with some of the point mentioned by you guys, but is there more information regarding the job firing? Is it due to poor performance, ...
I can not decide on which organization structure is the best. Dr. Simon mentioned pros and cons for each, so I think the best approach is to have a co...
I agree with @sts27, in the sense that both upper and middle management have overlapping functions and similar skill sets. However, I think there is a...
Yes, I agree with you. Like the DDP and many other documents, the Risk management documents must be updated on a regular basis throughout the entire o...
Like many of you stated, post-market risk management is extremely important for any device, biologic, or any invention for that matter. It assures lon...
When performing the Risk Assessment of a new medical device, I think all three tools serve a purpose and can potentially identify risks that the other...
Interesting posts. I agree with many of you in regards to the importance to diligent record keeping and constant updating the DHF. It is in fact a "li...
As pointed out by Dr. Simon if a medical device is a component and not directly used by the patient then the user needs and the specifications are ess...
I agree with many of you regarding the importance of design control for the benefit of the not only the patient, but also the company developing the d...
I have very little experience on this topic, therefore it was very good and informative to read your comments and experiences designing statistical pa...
An example I can think that would require many different validation processes in order verify that it is doing what its supposed to is an artificial h...
This is a very interesting post since I do not have much experience with this topic. I have been involved in validations and the development of labora...