Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru

Latest Episodes

#335: Accelerating SaMD Development in a Compliant Agile way
September 08, 2023

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

#334: MedTech Funding and Preparing for Due Diligence
August 31, 2023

Description:Join Devon Campbell in MedTech funding. He unveils startup red flags, from data integrity to product maturity. His message? Know your weaknesses, fill the gaps.Considering cold-calling other Founders? It works. Understand your their investment

#333: Exploring Breakthrough Device Designation
August 24, 2023

Description:In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episo

#332: Regulatory Strategy and the Advantage of Diversity in MedTech
August 17, 2023

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Ve

#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues
August 09, 2023

Description:During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of star

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?
August 03, 2023

DescriptionIn todays episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode. Som

#329 The Right Way to Start a QMS: When, How, & What
July 26, 2023

DescriptionMost people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've built it to the point it can stand on th

#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices
July 20, 2023

DescriptionIn April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's epis

#327 Understanding the ROI of an eQMS
July 11, 2023

In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:3rd- party study by Hobson & CO that reveals signifi

#326 CSA vs. CSV: Modern Validation for Modern MedTech
July 07, 2023

In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the