I would probably say that this is more a case by case approach. For devices or features that are high risk, verifications and validation should be str...

How about instead you design the DHF around making it easier for the reviewer to read it in mind, rather than the regular documents? Starting with a o...

Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn't pass regulation be rejected immediatel...

An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legibl...

Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matte...

While GCP regulations can slow development, the FDA has several programs in place that see to expedite the wait time. In class when learning about the...

You can make medical device marketing more ethical and accurate by doing a human-factors testing, something similar to testing that's done during devi...

I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into t...

For marketing products in general, knowing who your audience is can determine how to optimize your marketing strategy towards that audience. For medic...

Physicians branching out into entrepreneurship can have positive effects on healthcare. However, access can also be an issue with newly developed tech...

I think that the corporate veil is an important protection that allows people to take on the risk of starting a company or investing in one in the fir...

Obviously, AI is already being heavily researched and expanded on, with many companies finding way on how to seamlessly implement it into their system...

It's true that having things be more measurable makes it easier to provide clear results. One way I see of preventing that can be to create a checklis...

While creating one unified quality system sound more efficient, it can actually create more problems when companies work in different regions. Dependi...