Last seen: Nov 29, 2025
I think the restrictions with regards to what can or cannot be gifted to physicians is entirely necessary. If there was no restriction to what can be ...
If I were the owner of a company, I would definitely have a team of people fill in so that the continuity of the project and overall project deadlines...
From some of my industry experience, I had to sign an NDA form in order to work for the company since I would be working on next generation implants. ...
Organizational culture and structure are closely linked because the way an organization is arranged strongly shapes how people communicate and collabo...
From my experience in industry and through capstone projects, it's best to prioritize working with people who have the specific skillset in their resp...
A project manager can face very different challenges depending on whether they work in a matrix or a project-based organization. In a matrix structure...
The reason these standards cost money is because organizations like ISO and ASTM are non-profit bodies that fund their operations through the sale of ...
I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying ...
A real life scenario of hazardous material causing significant harm would be in 2004 at the Centers for Disease Control and Prevention (CDC), where a ...
Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled ...
I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, vali...
I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, vali...
I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry towar...
Yes, I do feel safer knowing that validation and verification are applied to medical devices we use today and may rely on in the future. These process...
The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using eng...