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 understand the terms you…   Read more»

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 too? I dot think this is…   Read more»

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 too? I dot think this is…   Read more»

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 organization. I can…   Read more»

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 involved with the progression of the company…   Read more»

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 been proposed of thought of…   Read more»

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 not have been seen during planning, design, fabrication,…   Read more»

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 in different stages….   Read more»

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 need continuous upkeep to…   Read more»

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 not necessary for that…   Read more»

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, implementation of the device, and even new…   Read more»

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 related to this that I have is meeting manufacturer standards…   Read more»

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 laboratory to mimic its…   Read more»

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 had the chance to work…   Read more»

This is an interesting topic and it is also interesting to see that some people chose the Utilitarianism approach, where the “justified” scarifies of life is thought to be okay, as long as it served a higher purpose of benefiting…   Read more»

This is indeed a sensitive topic since are dealing with the death of a person, however, before accusing someone, an investigation must take place to evaluate the root cause of death. Also, the question itself is very vague; are we…   Read more»

There are pros and cons for these types of studies. Like you mentioned, they are able to gather a lot more clinical evidence in a shorter time than a single trial and can encompass a larger number of patients that…   Read more»

@maniakberk You present a good point in portraying a limitation on the degree of relevance of EI to other markets. However, from reading the article I think the main point of EI being an essential part to customer retention and…   Read more»

Both Project management and sales need to work hand in hand to make a good sale, meet quotas, and maintain company stability. However, these are completely separate roles. As Dr. Simon described it, QA PM is like a mini CEO…   Read more»