When answering this question, I am tempted to say that the risk should strive for a zero-chance, but that is impossible. Devices and products will alw...

There are a few conflicts that could arise when it comes risk management and the project team being involved in the same tasks. One is the distributio...

When discussing mitigation going "too far", I think it is important to analyze whether a control is actually improving the device in an impactful or m...

Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude wit...

I think balance really can come down to defining the purpose for each document tier. Perhaps removing informal working logs or notebooks that are not ...

Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry ...

Yes, I, along with a lot of others I am hoping, do feel safer knowing medical devices go through the verification and validation process not just now,...

To me, balancing the user needs alongside business goals seems like a hard challenge to accomplish, although also an important part of the development...

While I don't currently work in the medical device industry, the understanding and learning of the difference between verification and validation are ...

The placebo effect is a great example of how phycological and physiological systems in our bodies are so deeply intertwined with each other. This make...

Biomedical engineers I believe play a significant role in clinical research and can be the bridge to piece a lot of aspects together. The background i...

While clinical research can feel like it's being weighed down by the scope of the idea or complexity, every process and layer within it from approval ...

I know I am not unique in saying this, but I feel a little invested in answering this because I had to go through the process of getting a dental impl...

There is such a wide variety of medical devices out there and variations that innovation on its own would rarely help in its own success, or at least ...

Marketing plays such a critical role in the diffusion of medical devices and technology, but in regards to healthcare, persuasive communication and th...