I would like to add that it would be very costly to re-validate everything. Imagine there is mass production. This "critical machine" might have produ...

Hi, I agree with most of you about the fact that the device needs to be validated again once it's moved because you don't know what could have changed...

Some critical-process standards include a requirement for re-validation at "defined intervals", and to require that those "intervals shall be justifie...

I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical W...

I have never worked in the industry. With my very limited related experience, I think the best set up of QMS depends on the size and function of the c...

I think it's always good to validate. I agree with @bb254 about engineers being trained per the SOP's of the company and validating equipment. I think...

I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it's needed to have all the docs updated once a...

I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiati...

I would add on to the list of various devices being classification differently between the US and EU with needle destruction devices. These are not co...

My answer is maybe not. Other than the lecture video, I have limited area about this topic so I did a search on it and found some interesting informat...

I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially ...

I agree with you guys about the facts that there is no specific "good number" in the number of centers, multi-center clinical trials (MCCT) are expens...

I am not working in the industry but my related field is vestibular rehabilitation. Currently, the focus of the field is toward automated systems and ...

I agreed with others about the differences between a patent and an NDA and how a patent gives you a legal proof of idea ownership. I would like to add...

hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what ...