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 produced thousands of products if not more. I agree wit...

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 during the process.But depends on the condition, ...

Some critical-process standards include a requirement for re-validation at "defined intervals", and to require that those "intervals shall be justified". (Language of ISO 11135-1, EtO Sterilization.) ...

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 Writing as an undergraduate course, I was good but ...

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 company.If the company is very small, it's ineffect...

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 every employee, not just engineers should be made...

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 revision is made. I also agree that it's a lot of...

I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily ...

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 considered medical devices in Europe but they are cl...

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 information. From the lecture, various reasons you guys ha...

I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep...

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 expensive, there are a lot of aspects involving in MCCT....

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 incorporating VR into physical rehabilitation. On ...

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 to the idea of using NDA to protect ideas and inv...

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 information is considered confidential (definition...