I do not have any experience, but I found an article about the regulatory pathways of drug-device and device-drug combination products on the EU from ...
Guideline documents are documents that generally clarifies a directives or regulation, as Dr. Simon mentioned, they are not mandatory but they are con...
From what I learned during the lecture, I think it is easier for a medical device to be approved. The directives does not give you a "one size fits al...
It also important to consider that a multi-center clinical study is more complex -in terms of coordination, quality control and data management- and v...
Yes, I agree that 3D-bioprinting has become a very popular trend. I also became very interested on the subject during my senior project design. Partic...
Hi all, gh56 I saw that you have not been able to touch upon BioMems yet. I took this class during my last undergraduate semester and I would like to ...
The Civil Monetary Penalties Law authorizes the imposition of substantial civil money penalties against an entity that engages in activities including...
Another example of a kickback allegation that I found, was the $3 billion settlement agreement that GlacoSmithKline(GSK)- a British pharmaceutical and...
I have to recognize that I expected this course to be the typical course in which you learn a great amount of theory and then you have to memorize it ...
I also agree that organizational structure and organizational culture do influence the success or failure of a project. Organizational structure is th...
I would like to work in a project-based organization since I like the idea of working in a team that will only focus in one particular project that mu...
Hi hg93, I agree that a composite organization will be best suited since it allows a company to blend the functional, matrix and project-based type of...
I do not have experience in the industry but I found that the usage of the confidence, reliability, and acceptance quality limits (AQLs) to determine ...
I would like to add that FMEA is subdivided into two types: 1) Design Failure Mode and Effects Analysis (DFMEA): is an application of FMEA especiall...
Hi Dhairya, that is actually a good question. From my point of view, these is how I would do in case of a low or high severity. 1) Hazards that fall i...