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, and consistency of data‑driven action. Download the snapshot document to get a clear picture of your current state in minutes. https://methodsense.com/ep-6-what-qmsr-means-and-why-it-matters-now/

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 MedTech space.

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 transparency, strategic planning, and strong partnerships between founders, investors, and regulatory experts are essential to turning innovation into lasting success in the medical device industry.