All Episodes

#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey

#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth

#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian

#464: Why LLM Unpredictability is a Liability in MedTech

#463: Finding MedTechs Leading Voices with Sean Smith

#462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders

#461: Why Manufacturing is Part of Product Development with Mike Dolphin

#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead

#459: The Purolea Warning Letter & Validating AI in Medical Devices - What FDA Actually Requires

#458: What the FDA Actually Says About AI in Medical Devices

#457: Exploring the MedTech Commercial Valley of Death with Ryan O'Mahoney

#456: What You Don’t Know Can Hurt You: 483 Pitfalls and Regulatory Accountability

#455: MedTech Founder 101: Shifting from Corporate to Startup with John Schindler

#454: Bridging the Gap: Avoiding the MedTech Valley of Death with Dr. Adam Saltman

#453: Sustainable Material Selection in MedTech with Lucas Pianegonda