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 also agree with seeking legal help to fully understa...

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, disciplinary action or simply because they wanted ...

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, disciplinary action or simply because they wanted ...

Since we are on the topic of company organization, structure, and managerial hierarchy I think this topic applies. In my company there is a functional organization structure, where all employees answe...

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 combination of two; a project based and matrix organ...

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 difference in tasks, while upper managements is i...

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 of device development since all risks may not have ...

Like many of you stated, post-market risk management is extremely important for any device, biologic, or any invention for that matter. It assures longevity of the device and evaluates risks that may ...

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 do not. I also believe that each tool can be used...

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 "living document" as it was pointed before and will n...

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 essentially the same thing and design validation is n...

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 device. Documentation regarding changed in design, ...

I have very little experience on this topic, therefore it was very good and informative to read your comments and experiences designing statistical parameters for testing controls. The only experience...

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 heart valve. The valve must have been tested in the...

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 laboratories by acquired CLIA and others, but have not h...