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 respect to equipment/instruments the company may have a template on…   Read more»

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. I know for sure that there…   Read more»

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 device directive, medical device directive and in vitro diagnostic device directive. But…   Read more»

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 addition, the FDA was…   Read more»

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 we acquire the ability to develop artificial organs, then this…   Read more»

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 drug been released,the US market would have…   Read more»

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 when compared to band-aids for example. Essentially…   Read more»

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 mentioned, if there are not…   Read more»

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 closely work with Quality, R&D and manufacturing…   Read more»

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 agency standards, and are safe.I know with respect…   Read more»

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. With Respect to the diagnostic microscope, it would not…   Read more»

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. With Respect to the diagnostic microscope, it would not…   Read more»

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 detailed, because often times these contracts…   Read more»

Hi All, I am currently working at Ethicon within Operations. As some of you may know or if you don’t know Ethicon is known for developing surgical devices or materials. One such device that they are widely known are there…   Read more»

As a lot of people mentioned before, the biggest different is mainly documentation. A written contract is easier to dispute in court when compared to an oral contract. Often times, what is said can be interpreted indirectly or may imply…   Read more»

Hi Roberto, In my opinion, I don’t think its too restrictive, you want to keep business within business, particularly with physicians, you don’t want to introduce bias to what your selling or attempt to bribe the physician. As Dr. Simon…   Read more»

As everyone above mentioned, this course really showed me how the medical device industry works, especially since I just started working within the medical device industry; this course proved to be a guide for me and a reference during work….   Read more»

Hi Lamiaa, In my opinion working for in a matrix organization is more difficult for the project manager, due to the fact that cross functional team situation, such as sharing resources and staff. Often times multiple team members are involved…   Read more»

I have worked within both divisional: product-based and matrix organization. I would still consider the matrix to be organization structure of choice.In my experience within product-based, there were always issues regarding statuses or approvals from other team, communication was often…   Read more»

Based on my current work environment, I would say my work organization is a matrix organization. I work within the operations division as manufacture engineer, so I closely work with multiple groups and I report to multiple managers. So far,…   Read more»