I definitely agree with the posts above, the design control in particular that should be reevaluated should be the verification/validation aspect of t...
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 ensur...
From my experience with Validation and Verification, I have particularly worked on lab equipment or instruments used to make or inspect a particular m...
Ideally they should have a set system or a method to prevent these tragedies. My only exposure with respect Regulatory agencies within the European un...
Although, I personally have never dealt with the European Union regulations for medical devices, from what I understand medical devices adhere to thre...
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 ...
Artificial meat is an interesting concept, but with respect to long terms effects, would the increase in chemical intake effect/compromise our bodies?...
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 lo...
Hi Roberto, it really depends on how invasive the device may be, which will categorize the medical device. For example, the implantation of coronary...
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 patient...
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 t...
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, t...
Design validation means that the right device was designed for its intended use, such as users requirements. 1) A diagnostic microscope slide that de...
Design validation means that the right device was designed for its intended use, such as users requirements. 1) A diagnostic microscope slide that de...
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 contract...