The MDR is complex, we all know that. But imagine trying to translate these very complex and multi-layered regulations

If you've ever wondered how leanRAQA can help your company, here's a brief, thirty-thousand foot view of what I do, and

Keep your fake and unregulated masks on, folks. These highly-anticipated vaccines ain't necessarily gonna make the

"If the public knew how insecure so much of the equipment is out there, they would lose their faith in the medical

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