Podcast

October 26, 2022

056 – “Non-Promotional Compliance” with Darshan Kulkarni

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. Darshan and I discuss: Key

October 19, 2022

055 – “Critical Tasks and Knowledge Tasks” with Alexandra Benbadis

On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss: Key Topics Critical Tasks: What the guidance says , how to select them

October 12, 2022

054 – “EUDAMED” with Richard Houlihan

On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss: Key Topics History of Eudamed (Starting with EU Legislation in 2010) The 6 modules

October 5, 2022

053 – “Duct Tape and Bubble Gum” with Chris Tsai

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Chris Tsai is the Director of Implementation at Boothroyd Dewhurst Inc. Chris is

September 28, 2022

052 – “All Work is Process” with Larry Mager

On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more

September 21, 2022

051 – “EU MDR” with Bassil Akra

On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss: Dr. Bassil Akra spent the last year supporting medical device, in-vitro diagnostic,

September 14, 2022

050 – “When No One is Listening” with James Somauroo

On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss: James is the founder of SomX: The Healthtech Agency and

September 7, 2022

049 – “What Does the Data Say?” with Shannon Hoste

On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: Key Topics FDA Human Factors Review for Combination Products (CDRH,

August 31, 2022

048 – “Materials” with Hsinjin Yang

On this episode of the podcast, I was joined by Hsinjin Yang of Pioneer Scientific Solutions. Hsinjin and I discuss: Key Topics Materials for Biomedical Applications Mechanical Properties, Physical Properties,

August 24, 2022

047 – “Truthful Not Misleading” with Darshan Kulkarni

On this episode, I was joined by Darshan Kulkarni, of – Free Speech and Promotional Compliance – Misbranding – Regulatory vs. Legal Compliance – From Congress to the FDA –

August 17, 2022

046 – “Inflation Reduction Act” with Sarfaraz Niazi

On this episode of the podcast, I was joined by Sarfaraz Niazi. Dr. Niazi and I disucss: Key Topics The Inflation Reduction Act Out of Pocket Costs Part B and

August 10, 2022

045 – “Combination Products around the Globe” with Susan Neadle

On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: Key Topics CPC Summit

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