Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’
Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Erez Kaminski, CEO and founder of Ketryx, which assists clients in creating FDA-regulated software. He updates us on the latest and greatest in digital health regulations, including PCCPs, decentralized clinical trials, and AI/ML software. We talk about some of the challenges and opportunities that often arise from these regulations, and Kaminski shares a personal story about why the safety of medical devices matters so much to him.
Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’
Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.