Last seen: Apr 24, 2022
I have experienced a solution to this quality and r&d integration problem. A separate department called "Advanced Operations" assists the R&D ...
Technology such as AI can be helpful in developing semi or fully automated quality inspections processes. I think it's important to note that these ne...
Quality Assurance is the methods used to ensure a product is suitable for the market. The methods include all of the systems, structures, reviews and ...
I agree that many new medical devices have no business being compared to 40-year-old devices. One of the primary benefits of a 510k is to bypass long ...
A physician would likely have a hard time developing their own medical device. The design, development, verification, and validation phases can prove ...
The FDA's strict regulations are often based on incidents where the lax of regulations caused harm to the public. The 1902 Biologic Act was instituted...
My first consideration would be how the device interfaces with the human body. A prolong-use device like an implant would have to satisfy far more reg...
Industry research often has the benefit of short term results. With the goal of bringing a product or device to market, research is sought to be compl...
Research in Industry is generally completed faster due to strict deadlines. The time management risks of an industry research project should be accoun...
From my own experience and from most of the replies on this thread, Microsoft Project seems to be the most popular software. During my undergrad, and ...
Multiple project managers could be a good idea depending on the scope and hierarchy of the project. In a large scale project, large or complicated tas...
Missing a milestone for a project should definitely be considered a failure. Failure to complete tasks on-time stems from poor estimation during the p...
Perhaps I can share my thoughts as a Mechanical Engineering student. When starting my degree, I always had intentions of working in the medical device...
My experience working in the industry is that the projects are goal-oriented. The project team works together to complete these goals and meet the des...
Speeding up the approval of medical devices certainly has its benefits. The COVID-19 pandemic has created a dire need for devices such as vaccines and...