Hi Fady!

Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring freeze or a travel freeze. Although new engineering projects start in R&D and core team leaders need employees to take on the workload, the managers of the R&D department do not allow them to hire new…[Read more]

Hi All,

I would also like to agree with all of the responses above. To put it in simpler terms, Corrective Action is based on a nonconformance event that has happened in the past, and Preventative Action is based on preventing a nonconformance event in the future. Thus, if you both the two together, CAPA is an integral part of a continuous…[Read more]

Great question! Gh56 goes into wonderful detail about the pros and cons of conducting an internal audit and I’m sure all students can agree with his response. From the time that I started working at the medical device company that I am currently employed at, I have been fortunate enough to be a part of two external audits and one internal audit c…[Read more]

GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that produce the devices must have procedures to comply with these regulations. Although I do not know an exact number to how often companies should improve/update their GMP requirements, I believe that…[Read more]

I agree with other students’ input in regards to companies choosing to not have GMP. GMPs typically cause companies to invest in a large sum of money, and to go through the hassle of understanding the regulatory system and requirements needed to fabricate proper medical devices. However, although there are advantages to not having GMP, there are a…[Read more]

Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general requirements to follow. The ambiguity allows for debates to arise and it makes the company question “where do we begin?” Due to the uncertainty, the company would struggle, and ultimately find a way…[Read more]

Hi Dr. Simon!

The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control and capable of consistently meeting specifications. I believe that both the FDA and ISO still require “full” verification for a process that supposedly did not need validation. While the wording of…[Read more]

If the equipment gets moved from one location to another, I do not believe that all processes have to be revalidated. The reason the quality team argued that is because if the equipment was assembled in a different location, this might lead to error due to improper setup or a setup in a completely different environment (percent humidity,…[Read more]

Hi Chris!

The ideas of the holistic engineer embodies the point of view than an engineer needs to consider the whole system, the body of work that makes a product successful. The engineer participates in each phase of product development and is explicitly tasked with making a product succeed. Thus, the holistic approach involves product…[Read more]

Hi Luisa,

I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily processes conducted to assure execution of research tasks in accordance with federal guidance. They should contain adequate detail to clearly guide research staff through a particular procedure and t…[Read more]

Hello!

To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might be necessary to respond to safety issues, market demand, or FDA requirements ECOs are documents that a company uses to track product changes. I currently work in a medical device technology company,…[Read more]

The FDA uses post-market surveillance to monitor the safety and effectiveness of medical devices once they are on the market. It is a regulatory requirement and a system that provides continuous feedback about the device on the market in order to maintain a high standard of product quality. Thus, the feedback and data that is collected is very…[Read more]

I believe that the DHF is more useful than the Tech File/Design Dossier. The FDA is highly concerned with a company’s DHF because it involves everything from risk analysis to an end product where product specifications and customer needs are verified/validated, respectively. The files are very important in both the design and development process o…[Read more]

Although it is easy to mix up the concepts behind design verification and design validation, both of them consist of different aspects that ultimately combine to form part of the Design Control. Design Verification confirms that the design output meets the design input requirements. Thus, it confirms that the design meets the product…[Read more]

I agree with the students who believe the DHF is a living document. If any change is made to the medical device, the information should be included in the DHF. If a certain part of the device is altered—such as a material change—then the change has to be looked at in terms of how it’s going to effect the entire product. Since the DHF is a compi…[Read more]

The answer that I am about to state is based on the links Dr. Simon posted on this week’s lecture and my understanding of the documents. The Guideline Documents are not mandatory, but they certainly provide a way to follow a directive. I would consider the NB-MED Guidance Documents to be the most useful for getting a device through the r…[Read more]

Hi Fady!

I do not have experience with filing combination products in the EU. However, in my opinion, it seems like a major hurdle would be choosing a Notified Body that is capable of evaluating combination products and completing paperwork associated with the conformity of the product before being placed on the market. The evaluation by a…[Read more]

After listening to the lecture, it is clear that it is easier to get devices approved in the EU for several reasons. The EU bases their classification on an essential requirements checklist and on risk. In the United States, regulation by the FDA was created because products were harming people due to improper labeling. Thus, as per the FDA,…[Read more]

I do not have any experience with working with PMOA for a combination device. After doing research on this topic, I have come to the conclusion that if a company cannot identify a PMOA, a Request for Designation can be submitted to the FDA to determine the classification of a combination device. Additionally, before submitting the request, a…[Read more]

Hi Fady,

You made a very excellent point because there is definitely a greater chance of data distortion if too many centers are present. Variability needs to be controlled and in order to do so, the scope of the study needs to be clearly defined and those who are conducting the study in the center (operators) need to be trained properly because…[Read more]