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
Navigating Audits in Med Tech and Pharma: A Conversation with Jim, CEO of RX-360 In this episode of the Combinate podcast, host Suby interacts with Jim, CEO of a member-driven
On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member. Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side
In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device. Munir shares his expertise on the often confusing topic
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David discusses his broad background, including his roles in quality manufacturing, product development, and technical
