MedTech Smarts with Rita

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 pressure. Rita King and Evangelia Evdaimon explain how to connect quality, regulatory, risk, complaints, and post‑market activities into a truly inspection‑ready system, and why AI-enabled eQMS platforms like Lumi...

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 to successfully transition to this more proactive, integrated approach to quality management. Our QMSR Readiness Snapshot helps you assess how your organization truly operates: decision‑making speed, information flow across teams,...

In 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 a product. She explains how understanding FDA definitions, designing with compliance in mind, and aligning your marketing language can help founders move faster, gain investor confidence, and build lasting credibility in the MedTec...

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 Shavini’s journey with OxiWear, a pioneering pulse oximeter, the conversation explores the hurdles of FDA submissions, the pressure of investor expectations, and why early collaboration is critical. The discussion highlights how transp...

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 timelines. Special guest Nikin Shah reveals how creative lending and strategic partnerships offer fresh pathways for growth, while experts Rita and Richard share actionable insights for leveraging regulatory pl...

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 realities of building a medical device startup from securing funding to navigating FDA clearance. Join industry veterans Rita King and Richard Holcomb as they unpack what most founders wish they'd known early on so they could get...

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 about advancements at the FDA: their new artificial intelligence tool, Elsa. Anna and Rita break down what Elsa means for MedTech executives, why it’s making waves in the industry, and how this tool could shape the future of medical device regulation....