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

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

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

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

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

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

DescriptionIn April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled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

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

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 She discusses the FDA's draft guidance from September 2022, the

How can dFMEA and ISO14971 work together? This topic is controversial but essential, and todays guest is more than capable of tackling it. Risk management is one of the top 3 reasons why the FDA issues 483s, so its important to understand.In todays epi