This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance – Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance – Questions
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: Timestamps 00:31 Larry's Perspective on Quality 03:21 Importance of
On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through: Timestamps 00:38 Exploring
On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: Timestamps 00:29 Design Changes When No DHF
On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: Timestamps 03:11 The Formation and Impact of
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
