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 the NSF. In the key points, they clearly state tha...

Guideline documents are documents that generally clarifies a directives or regulation, as Dr. Simon mentioned, they are not mandatory but they are considered and accepted as the best way to follow a d...

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 all approach" instead there are many ways,the confor...

It also important to consider that a multi-center clinical study is more complex -in terms of coordination, quality control and data management- and very expensive in terms of personnel and resources....

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. Particularly, I think the projects that wake forest are ...

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 give you a little information about it from what I...

The Civil Monetary Penalties Law authorizes the imposition of substantial civil money penalties against an entity that engages in activities including, but not limited to: 1) Knowingly presentin...

Another example of a kickback allegation that I found, was the $3 billion settlement agreement that GlacoSmithKline(GSK)- a British pharmaceutical and the world's sixth pharmaceutical company- had to ...

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 for the midterm and final. The fact that this cour...

I also agree that organizational structure and organizational culture do influence the success or failure of a project. Organizational structure is the foundation of how business is conducted internal...

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 must be executed in a timely manner. Traditional org...

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 organizations to help suit the company's needs. A...

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 sample sizes for process validation are used to en...

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 especially for product design. It begins at the development ...

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 into a low severity risk, are considered generally ...