Hi all, I have not had any experience with any ECO since I still do not have experience in the medical device industry. But to my understanding. some examples in which ECO is needed could be when a modification will…   Read more»

It is interesting to learn that Section 522 of the Federal Food, Drug and Cosmetic Act gives the FDA the authority to require a manufacturer to conduct post-market surveillance of a class II or class III device when the device…   Read more»

Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove that each design output complies with each specification created from the DID. Design validation tests if the design conforms to user…   Read more»

I believe that the DHF should be a living document that reflects the current state of the device. Keeping track of the changes (SOP’S, material, packaging, labeling..etc) and updating the DHF gives an appropriate and up-to-date information to anyone who…   Read more»

In my opinion, I think that the DHF is more useful. The reason for this is because this document is able to show a detailed and comprehensive design and development process until its release. Every change, every choice taken towards…   Read more»

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 that it is critical to understand…   Read more»

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 directive. I would have to agree with most…   Read more»

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 conformity assessment route, in…   Read more»

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. therefore it is essential to have an efficient central…   Read more»

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 performing with 3D printing are amazing since…   Read more»

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…   Read more»

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 presenting or causing to be presented, a claim for services not provided as…   Read more»

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 agree to in 2012. Besides the criminal plea agreement on off-label uses…   Read more»

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 course…   Read more»

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 internally and externally. It show us how operations are carried out daily…   Read more»

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 organizations focus on hierarchical…   Read more»

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. Also,it is important to know that a…   Read more»

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 ensure that validation activities will yield valid…   Read more»

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 stage. It is a procedure used…   Read more»

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 acceptable…   Read more»