Posted by: @rv347 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, “red knob”), whereas the DSD is design specification and gives a very specific description(ex,…   Read more»

I’m sure many of you chose the validation process, which is extremely important in design control; however, I think the most important step is customer input. Listening to the customer’s wants and needs then use it to create a product…   Read more»

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is…   Read more»

Great question, especially in the climate that we’re in with the rise of monkeypox. A lot of factors come into this play such as race, geographics, health status, age, sex, and who has access to medical care. To investigate your…   Read more»

I think it’s absolutely ethical because this procedure is preventing data error. I do understand the reason why you would think this practice is unethical due to the fact that you’re tricking the patient, however using the placebo control trial…   Read more»

I think at the end of the day, it all depends on your preference. I’m inclined to agree with you on this subject. I believe in the single blinded is generally better than the double blinded study, simple because it’s…   Read more»

I think at the end of the day, it all depends on your preference. I’m inclined to agree with you on this subject. I believe in the single blinded is generally better than the double blinded study, simple because it’s…   Read more»

I think at the end of the day, it all depends on your preference. I’m inclined to agree with you on this subject. I believe in the single blinded is generally better than the double blinded study, simple because it’s…   Read more»

I think at the end of the day, it all depends on your preference. I’m inclined to agree with you on this subject. I believe in the single blinded is generally better than the double blinded study, simple because it’s…   Read more»

I think at the end of the day, it all depends on your preference. I’m inclined to agree with you on this subject. I believe in the single blinded is generally better than the double blinded study, simple because it’s…   Read more»

Private Companies doesn’t answer to any stockholders, follow regulations issued by the SEC, and they have the right not to disclosure any information. Public companies on the other hand must obey the regulations rules by the SEC; however, the primary…   Read more»

There are pros and cons to every business structure, so it all depends on what type of business you’re in and what product you’re offering. Depending on what state I’m operating my small business in, ideally, I would want Limited…   Read more»

I think working in a workplace with diversity is encourage is an advantage I think all companies should have. I learn and respect all people that has a different background than me. They teach me things that I haven’t experience,…   Read more»

Good question. I would think ethics and quality control go hand to hand just based off this week’s lectures. The FDA ensures the quality and safety of the medical device as it is being practice. Good ethics is heavily enforced…   Read more»

Since I have a bachelor’s degree in business administration with a concentration in marketing and communication, I think I would pursue a role in the marketing department of Quality Assurance. I enjoy branding and understanding my target audience/ demographics. Developing…   Read more»

I think the common medical devices hospitals use are in fact drugs/pharmaceuticals. Knowing the stability life of pharmaceuticals is important because they need to know the product’s storage life, storage conditions, and the overall quality for patients. Drug companies must…   Read more»

In a perfect world, we wouldn’t use animals for clinical research or have them in zoos; however, we don’t live in a perfect world. I do understand the concerns from many people about the use of certain animals in our…   Read more»

Posted by: @cruzdonato Research in industry can be volatile due to time and money constraints. Sometimes, corners need to be cut in order to meet deadlines or cut down costs. What do you believe is the deciding factor between a…   Read more»

There are some benefits on working in academia such not having to work long hours, meeting genuine good people, possibly discover groundbreaking medicine or therapies, and of course the flexible work schedule; however, I find this career path not for…   Read more»

Posted by: @efields30   Regulatory Affairs is a industry that ensures the safety of the public when overseeing food, medical products, and drugs. This management make sure companies making medical devices comply with FDA regulations. What could be an example…   Read more»