On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: Timestamps 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29
On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry. Devon discusses: Timestamps 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: Leo Eisner, founder and principal compliance and regulatory
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss: Key Topics Assessing Drugs, Devices, and Combination Products for Sterility Methods
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: Timestamps 00:58 Exploring the Impact of QMSR on Medical Device Companies 02:19 UDI
On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about
On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: Timestamps 01:35 Journey from Premed to FDA Investigator: VIN's
On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to
On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: Timestamps 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations (QMSR) Final Rule that was issued by FDA in early February 2024. Timestamps
On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship,
On this episode, I was joined by Peter Baker, President @ Live Oak QA. The conversation revolves around the speaker's experience working with the FDA, starting from his time in
