Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps t...

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or c...

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for...

Artificial intelligence has been up on the rise as of recent years, but it seems to be slowly taking over this past year. I have not seen this much us...

Clinical experiments require human testing and this is usually done after preclinical trials have passed in animals and are deemed safe to perform on ...

Reading all of the responses, I would like to disagree that the placebo effect cannot have any negative effects on a clinical trial. I think that plac...

Generally, almost every company is going to be affected by external factors like the weather, politics, economy, competitors, and collaborators. There...

People who are designated in branding control the product’s image. I feel like I may be able to do a good enough job in that department. I do not have...

In terms of marketing, we all have seen those drug commercials on TV where it is usually a patient describing their story and how this medication save...

First and foremost, I think it would depend on the business you want to build, the location, the size, and the need for your product or services. For ...

In research labs, it seems like creativity and productivity is easier to achieve than in corporations. For example, research students, facility mentor...

I believe that many business owners or those that go into entrepreneurship prefer an LLC over an LLP due to the flexibility over ownership with the bu...

I do not have much experience with the industry and medical devices for quality control, but I do have experience with our quality control department ...

Every user has provided good points on who would be beneficial to be a panelist in a FDA advisory panel. I agree with torikul as they have highlighted...

In this week’s lesson, we have learned that quality assurance makes sure that all of the systems, structures, reviews, and evaluations meet the requir...