Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA staff can uncover not-so-good manufacturing practices, such as contaminated drugs or vials that are being used…   Read more»

Recently, I was involved in a single blind user study at work that involved our production parts and an R&D part that will be available on the market within the next year or two. As Dr. Simon mentioned in his…   Read more»

The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-saving strategies. That being said, I agree with neb2 because manufacturers of medical products have pursued…   Read more»

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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»