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 the design of the device, every mistake and every path taken is in the DHF and anyone that open the DHF is able to…[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 the main mode of action of the product since that will determine whether it will be regulated as a medical device or…[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 of the forum, that NB-MED guidance documents are the most important and useful to follow since they are…[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 of the forum, that NB-MED guidance documents are the most important and useful to follow since they are…[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 of the forum, that NB-MED guidance documents are the most important and useful to follow since they are…[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 of the forum, that NB-MED guidance documents are the most important and useful to follow since they are…[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 which not all articles in the directive apply to the device and there are different route choices that can be applied to…[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 coordination of all trial activities and adequate funding since the beginning. it is…[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 they are using this technology towards military applications. Currently, they have two 3D printing…[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 understood from the class. First, BioMems stands for Biological or Biomedical micro-electro-mechanical-systems. In terms of meters, we are talking…[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 claimed or which is otherwise false or fraudulent in any way.
2) Knowingly…[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 and safety data omissions, under their civil settlement agreement, the…[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 was not like I expected it to be, really impressed me. I enjoyed every single lecture and most important, I learned about how the real medical…[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 and how projects are integrated within daily operations. While organizational…[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 structure (such as whom you must report to), functional questions (such as the nature of your job) and operational…[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 composite organization does not really mandate the use of all three, any blend of the three types can be used and…[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 results based upon an organization’s risk acceptance determination threshold, industry practice, g…[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 basically in engineering to explore the possibility of a design failing in a real-world situation or use. It is a…[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 basically in engineering to explore the possibility of a design failing in a real-world situation or use. It is a…[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 and will not require further analysis. Additional mitigation can be done but is optional for hazards that fall into low severity…[Read more]