In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive exp

In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer

In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of hiring and job seeking in the MedTech industry in 2024. They discuss strategies for

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru. Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition

In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the val

In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medi

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials.

Description:In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (suc