I am not aware of any company that does this and if they did I’m sure it would be held close to the vest. While this strategy may work in the short term to avoid displaying the failures of a…   Read more»

@mmd55 As you mentioned, TMV are important for proving that the way we are testing the medical device is accurate and consistent, ensuring the decisions made about the product from the result of that test are valid. In the medical…   Read more»

I work in R&D Lifecycle Management so our design change projects are an update or change to an existing product, not the development of a new product. However, we still use design controls to run these projects. 1.Planning – In…   Read more»

I am not personally aware of any companies that openly promote this, but there are definitely cases of negligence that, when caught in an audit, result in a CAPA (corrective action preventative action) that requires a lot more resources, time,…   Read more»

Pro and Cons might be little out of character this as one if necessary for the other. For the instance given, one needs a basic understanding of the door knob example, if one doesnt know that a door knob is…   Read more»

In the past have had the responsibility to maintain and update a very large Gantt chart, as it was pertaining to key project in my previous company. One thing that was mentioned above but will reemphasize is connectivity between each…   Read more»

I think this is very interesting topic of discussion as its applicable to majority of the students as at some point they will have to worry about meeting minutes. In my opinion I think they should be based on individual…   Read more»

That is true, it can be pretty expensive and not financially efficient for a clinical trial company to have to pay each participant subject for partaking in the study. Other than money, another qualifying incentive that could possibly attract potential…   Read more»

I believe that the majority of the reason for why clinical testing/trials are done for pharmaceutical drugs is to document any potential or inherent side effects that may transpire when taking the drug. If there is documentation of a person…   Read more»

Placebo controlled trials are ethical from a bigger picture sense. There is a greater good at hand when conducting them. It is for a good and moral purpose, so therefore, it should not be considered unethical. They are necessary for…   Read more»

I believe that the biggest difference between single or double-blind studies is the psychology behind it. Depending on the situation it may be useful to conduct one as opposed to the other. In the specific example given I don’t think…   Read more»

Well first and foremost, the purpose of any clinical study is to ensure the wellbeing of the public. That is the point of the study, you’re running trials to make sure it’s not detrimental to a person’s wellbeing. Now, as…   Read more»

In terms of the ethicality of placebos, I believe they are very ethical because you aren’t actually doing anything to the patient. In terms of necessity, I believe they are very necessary. I’m a firm believer in medicine when treating…   Read more»

Though incentives are offered to attract participants to join clinical trials, candidate selection plays an important role in accomplishing a successful research study. Therefore, picking randomized contestants and performing double-blind procedures will help minimize the selection bias. A double-blind study…   Read more»

Double-blind studies mean neither the experimenter nor the participant has any clue about the study or treatment. That helps to get the best possible results out of the experiment. Since the experimenter is also clueless about who is receiving the…   Read more»

Clinical research is significant in determining the safety and effectiveness of medications and medical devices. I agree with the above posts that discussed different aspects and the importance of clinical research on human trials. Undeniably, there is always a possibility…   Read more»

An instance were I had to create a Gantt chart for the project which I was working on was actually my first time doing so. I think the key when creating one is to have in mind that the Gantt…   Read more»

Posted by: @orleron The DMR is largely used for US products. It is required by the FDA. The equivalent to the DMR for European products is called the Technical File (for European class I, IIa, and IIb devices) or the…   Read more»

While both documents are extremely important and I don’t think either has any major cons. However, I will point out some flaws with both documents.  The design input document is important because it gives the broad idea and basic desire…   Read more»