These restrictions exist to prevent even the appearance of influence on medical decision making. Even something as small as paying for a spouse’s meal...

While there are situations where a verbal agreement may be legally binding, using a verbal agreement as an alternative to a written contract is extrem...

Although both an NDA and a patent provide some level of legal protection, the two are not interchangeable. An NDA is a type of contract which prevents...

Risk acceptance does always involve acknowledging a higher probability of harm compared to avoidance or mitigation, but it does not mean the decision ...

In medical device development, true zero risk is essentially impossible, especially for implantable or life sustaining products. Even with extensive v...

A medical device’s risk profile is shaped by several key characteristics, including the severity of harm if something goes wrong, the likelihood that ...

I think many companies initially treat design controls as a regulatory checkbox, especially smaller startups rushing toward 510(k) or PMA submission. ...

I would argue that structured frameworks are the only reliable way to bridge user needs with design inputs. Translating a qualitative statement like “...

AI driven and adaptive algorithms in medical devices introduce a new layer of uncertainty. Unlike deterministic systems, machine learning models can b...

This is definitely an issue that can occur. Validation should confirm that the final device meets documented user needs and intended use, not hypothet...

A recent (2024) example of insufficient design controls is Tandem Diabetes Care’s t:slim X2 insulin pump mobile app recall. The iOS version of the app...

Verification is the process of confirming that design outputs meet the specified design inputs. This typically involves documentation in the Design Ve...

I actually think double blind studies are essential in many cases because they minimize both participant bias and investigator bias, which can uninten...

Personally, I would be more interested in the role of a Clinical Research Coordinator (CRC). The CRC is often the backbone of the trial and is respons...

I understand the concern about the risks involved in clinical studies, but I believe that human clinical trials are absolutely necessary and ultimatel...