MedTech Smarts with Rita Podcast Series

Welcome to the MedTech Smarts with Rita podcast series, a trusted source for regulatory clarity and strategic insight in the fast-evolving world of medical device and life science compliance. Hosted by Rita King, CEO of MethodSense and a recognized authority on FDA and EU regulatory affairs, this series explores the complex challenges companies face as they navigate product development, regulatory submission, and market clearance in an era shaped by AI, digital transformation, and heightened global scrutiny.

Stream episodes directly from our website, or enjoy listening through your favorite podcatcher like Spotify, Apple Podcasts, or Amazon Music.

Prefer the video experience? Each episode is also available in video format on its own dedicated page linked below.

MedTech Smarts with Rita

Ep. 7 – QMSR and ISO 13485: Understanding the Difference Between Compliance and Readiness

This episode breaks down why ISO 13485 certification alone does not make a MedTech company FDA-ready under QMSR, and why the real differentiator is operational readiness under real-world…

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Ep. 6 – What QMSR Means and Why it Matters Now

In this episode of MedTech Smarts with Rita, we break down the FDA’s new Quality Management System Regulation (QMSR), what it means for medical device companies and how…

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Ep. 5 – What It Really Means to Be a Medical Device Company

On this episode of MedTech Smarts with Rita, regulatory strategist Rita King breaks down what it means to operate as a true medical device company, beyond just building…

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Ep. 4 Regulatory Efficiency Under Pressure: A Founder–Expert Perspective

On this episode of MedTech Smarts with Rita, Anna Crooke, Rita King, and Shavini Fernando dive into the realities of bringing a medical device to market. Drawing on…

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Ep. 3 Funding Innovation: Smart Capital Strategies in a Tight MedTech Market

This week on MedTech Smarts with Rita, the panel tackles today’s toughest funding challenges in MedTech, from shrinking venture capital to limited grants and the impact on commercialization…

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Ep. 2 Before You Build It: Lessons from 25 Years of MedTech Startups

This week on MedTech Smarts with Rita, we're launching a special mini-series called "Before You Build It: Lessons from 25 Years of MedTech Startups." We'll dive into the…

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Ep. 1 Essentials for Navigating FDA’s AI Elsa

On this episode of MedTech Smarts with Rita, MethodSense founder and CEO Rita King joins Anna Crooke to take a closer look at one of the most talked…

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