#335: Accelerating SaMD Development in a Compliant Agile way

#335: Accelerating SaMD Development in a Comp...

Up next

#476: Part 2: FDA Guidance: What We Should Expect in 2027

In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The dis ...  Show more

#475: Part 1: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy

In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore h ...  Show more

Recommended Episodes

Software Development in the Evolving World of Medical Devices and Applications - with Urvashi Tyagi of ResMed
The AI in Business Podcast

Today's guest is Urvashi Tyagi, Advisor and Former CTO at ResMed. Urvashi joins us on today's podcast with Emerj Senior Matthew DeMello to discuss the unique challenges healthcare leaders face in driving software development efficiencies for medical devices and customer-facing ...

  Show more

Building Digital Health's Github
Raising Health

Today’s episode is all about the history and future of infusing tech into healthcare with the goals of improving outcomes and lowering costs, and features one of the leading voices in this field, Jonathan Bush. Jonathan, aka JB, started his career in healthcare as an ambulance ...

  Show more

Driving Development Efficiencies for SaaS - with Akash Gupta of GreyOrange
The AI in Business Podcast

Today's guest is Akash Gupta, Co-founder and CEO of GreyOrange. GreyOrange is a warehouse robotics and software company that works in apparel, retail, consumer electronics, and home improvement, among other industries. In a special series focusing on software development chall ...

  Show more