Specifically focusing on AI, it could greatly impact the jobs of QA individuals and aid them in making more effective SOPs, validation documents, etc. Utilizing AI to help improve certain processes an...

At the end of the day, both QC and QA are crucial to the success of a product line and a company in general. If a device is not properly prepared, manufactured, and then tested, it will be a failure a...

From my own understanding and experience, too many regulations or rules in quality control testing can definitely slow down progress. In my previous experience, I worked in industrial chemical enginee...

I think that regulations are extremely important for public transparency and risk reduction. They set a baseline of what needs to be done at minimum to allow for a product to go out onto the market, w...

I think the biggest aspect of the safe vs unsafe aspects of any medical device or product depends on the testing done, the science behind it, the public knowledge of it (papers or studies done on it),...

I think this is a great question, especially since there are new technologies being made that might not be able to be classified as easily. I do believe that the class I, II, and III system is outdate...

I would definitely say from a researcher's perspective, navigating the organizational and approval process is the more challenging part of pre-clinical development. If you think about a researcher pri...

From what I have learned and from the experiences I have heard from other people, animal variety can have significant effects on reproducibility, on both sides of the spectrum. For example, having dif...

I would definitely prefer industry when it comes to research for medical device development. The first reason is because of the availability of direct impact and visibility of the direct impact on pat...

In my opinion, missing a milestone is not directly a failure, although it does sound like one. For example, companies miss milestones all the time, but the impact the milestone has on the overall proj...

In my opinion, a project manager needs to have 1 main quality: openness. The manager needs to be open to ideas, open to the team, open to change, etc. When taking on a project, there are hundreds of f...

I can agree with a lot of the points that have been made before my post, specifically on the communication aspect and the openness with the team. In my opinion, it is important that if an individual o...

I think this is a great question that applies to basically everyone. I have though about this question often, since I have done both research and have industry experience doing internships. Personally...

@pz98 @vanshamin I think you guys brought up some great points about the use of AI in the medical device industry. I have read many articles and learned about how AI could effectively change factors l...

I do agree that a BME degree has disadvantages and advantages, but more on the advantages side. I have heard from multiple people that BME is too specific, in the case where you cannot do other jobs t...