I definitely agree with the posts above, the design control in particular that should be reevaluated should be the verification/validation aspect of this product. Risk analysis should be conducted as ...

I agree with the comments above validation and verification should be approached at the close stage of the project. The idea is that you want to ensure that it meets the user needs through validation ...

From my experience with Validation and Verification, I have particularly worked on lab equipment or instruments used to make or inspect a particular medical device in a manufacturing settings. With re...

Ideally they should have a set system or a method to prevent these tragedies. My only exposure with respect Regulatory agencies within the European union and the US market is within a cosmetic aspect....

Although, I personally have never dealt with the European Union regulations for medical devices, from what I understand medical devices adhere to three directives: the active implantable medical devic...

Hi all, As everyone mentioned above, it is easier to have devices approved in the EU, the main reason is that the regulatory aspect is not as strict when compared to the US regulatory agencies. In add...

Artificial meat is an interesting concept, but with respect to long terms effects, would the increase in chemical intake effect/compromise our bodies? I believe that when the technology enhances and w...

Great question Talha, The FDA's intervention to prevent the release of Thalidomide into the US market is critical to how important drug trials and long term effects should be considered. If had the dr...

Hi Roberto, it really depends on how invasive the device may be, which will categorize the medical device. For example, the implantation of coronary stent is more invasive and is a "riskier" device w...

Hi All, Great comments, and I do agree repeatability and traceability are vital for a clinical study, and it really comes down to is how many patients can be monitored and evaluated, because as Luisa...

From my experience, i feel that I work within a matrix organization, my team operates by function and product, which overall exposes me to different teams and projects. I've had the pleasure to closel...

Based on my experience with GMP, it is a vital practice that ensures companies in the eyes of regulatory agencies that there products are traceable, they meet all quality standards, meet regulatory ag...

Design validation means that the right device was designed for its intended use, such as users requirements. 1) A diagnostic microscope slide that determines the presence of certain stem cell markers....

Design validation means that the right device was designed for its intended use, such as users requirements. 1) A diagnostic microscope slide that determines the presence of certain stem cell markers....

Hi All, I haven't particularly dealt with contract, but I have dealt with the contractors that have done work within the facility through the contracts and from my experience it has to be very detaile...