@aca I don't particularly think there should be an emphasis on patient diversity as clinical trials are meant to be done for the potential population who will utilize the medical device. If patient di...

@ahmed-elmonier I feel like sometimes one can get away with not involving manufacturing until the later stages of medical device development, but I also feel like they can offer firsthand experience i...

I would like to discuss Botswana's regulatory system as this has not been mentioned yet. Botswana has historically had minimal medical device regulations but is increasingly adding a more comprehensiv...

One example of a medical test that was used in clinical research is the at-home pregnancy test which is a medical device thats regulated by the FDA. These tests detect human chorionic gonadotropin (hC...

I would like to focus on patient monitoring and risks during clinical trials as the other answer focuses on animal testing. Researchers need to regularly monitor patients throughout clinical trials to...

As the other responses defined much of the information regarding good clinical practices, GDP, and also gave a few examples, I wanted to discuss 21 CFR Part 11 which is electronic records and electron...

Yes. I think this is fairly important as developing markets view many medical devices in a much different lens than in the USA. This can be simply access. Marketing as having easy access to the device...

I feel like a certification would be highly beneficial to an aspiring engineer as this provides proof of knowledge in the business side of things. This can lead a candidate to a potential engineering ...

This one is not even direct advertising as I would classify it as indirect advertising. Creality makes some awesome 3D printers, and I love 3D printing. When one gets a product from creality, the prod...

I may be a bit biased, but even if I didn't help out in my family's LLC, I would still choose an LLC. They don't run that much risk compared to a sole proprietorship especially in a lawsuit, and I wou...

In my first internship, I worked at a relatively small private company that was in the middle of restructuring to go public. There was high demand for productivity and output. It was a bit surprising ...

As I was pondering the question, I couldn't help but think that it honestly wouldn't matter for the average engineer. Engineers, from my understanding, generally have a project to work out and are at ...

I have come across many of these experiences in the past, but I want to discuss one instance which I feel fits the prompt quite well. This is referring to my prototyping class as an undergraduate in w...

Some of these processes include change control. Corrective and preventive actions (CAPA), and post market complaints. In change control, embedded software might need updates once medical devices have ...

I’m going to discuss the role of the complaint specialist. Their main responsibility is to receive and document complaints that involve products that are out on the market and review the complaints to...