I think technology is always evolving and it is doing so rapidly so I do believe that QA should adapt to the rapidly changing technology. Tools like AI can be beneficial in making processes go faster and improve outcomes. I…   Read more»

I think that both quality assurance and quality control are crucial for patient safety. QA is important because it focuses on preventing issues before they happen. Through training, QA establishes clear processes and minimizes the chances of problems making it…   Read more»

I think the most efficient way for quality teams to collaborate with R&D teams would be for both teams to communicate with each other consistently. I think quality teams should be involved in the early development process so they can…   Read more»

This is a good question that is difficult to answer. I do not think that FDA approval means a drug or device is risk free. There have been many drugs that have been approved and put out on market but…   Read more»

A product that was recently recalled is Zantac. This is a heartburn drug and it was recalled in 2019 because of a cancer causing chemical called NDMA. This became clear after testing when it was in market. I do not…   Read more»

I think the best thing to do depends on the project and whether or not it’s a small startup or a larger company. For small startups, I think it makes sense to focus on the innovation first which allows engineers…   Read more»

I agree, preclinical research is crucial in making sure the safety before going through human trials. This is especially true for medical devices that could be a serious threat if something goes wrong. I do believe that animal testing has…   Read more»

I agree that choosing the correct animal model is crucial in research especially in neuroscience. Due to the brain being complex, using models that are close to human biology can improve the accuracy of the findings. Rodents are usually used…   Read more»

I think that both short and long term research have value. I believe that research that helps people right away is more beneficial. It allows the researchers to see how their work has improved people’s lives. I think long term…   Read more»

Missing a milestone is a failure, if you have a deadline you should be able to meet it if you are managing your time correctly. Being diligent of a milestone is important especially in the industry because if a deadline…   Read more»

It is crucial that the project manager deals with budget concerns by evaluating where all the costs can be allocated. When exceeding the budget, it is important that the project manager evaluates where the money is being allocated. Every single…   Read more»

I think that having a timeline when it comes to project management is crucial in ensuring an effective project. I believe that you need to prioritize all tasks efficiently and in a smart way. A timeline is important because it…   Read more»

I do think that medical device certification is an important step in the process of development even if it is not a main focus. I do believe that it is a useful certification to have considering when working with these…   Read more»

I do not believe that AI is going to control the medical industry but I do think it is going to change it. I believe that AI has the potential to affect the industry efficiently but it is not able…   Read more»

I think AI is one of the biggest improvements in the medical device industry. I believe that it can be used to improve accuracy and personalize treatments more efficiently. I have read that AI can identify things that are wrong…   Read more»

@vanshamin I completely agree that AI has completely changed the industry and how things work. I do believe that AI has made it possible to manufacture medical devices but I do agree that the FDA has made the process slower….   Read more»