Protective gear is in high demand, and it seems everyone is making masks. In this clip from Joe Hage's weekly COVID-19

In this episode of the RAQA Today podcast with Mitch Robbins, we discuss the impact of private equity and venture

In recent years, regulatory affairs has gone from the red-headed step child of an organization to a department with a

There is a HUGE difference between how the FDA will support you through a 510K submission and what your notified body

Startups have different challenges along the road to market release than do the larger, established medical device

Monir El Azzouzi has a new podcast with a very catchy name - Medical Device Made Easy. He invited me to participate in

I have seen some VERY dysfunctional organizations in my day. No matter the size or how long the company has been in

Many startups make the mistake of viewing regulatory affairs - and regulators - as a necessary evil, or barrier to

Biotech is one of the riskiest sectors to invest in, so potential investors need to be able to discern signals that a

As an investor, when the company making the pitch says "We are a Class I, II and III device!" your ears should perk up