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…
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…
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…
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.…
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…
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…
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…