Global Medical Device Podcast powered by Greenlight Guru
Health & Fitness:Medicine
In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.
Key Timestamps:Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at podcast@greenlight.guru
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Sponsor Segment:This episode is proudly sponsored by Greenlight Guru, a global leader in MedTech-specific software solutions. Whether you're in the clinical trial phase or ensuring compliance with quality standards, Greenlight Guru offers tailored solutions to streamline your processes. Their software is designed specifically for the medical device industry, helping companies accelerate their product development with confidence and compliance. Learn more about how Greenlight Guru can illuminate your path to market success by visiting their website at Greenlight Guru. Equip your team with the tools to simplify quality management and keep your focus on innovation and patient safety.
#369: Advice to Medical Device Inventors
#368: Institutional Review Boards (IRBs)
#367: Interviewing the Interviewer
#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
#365: Medical Device Reporting: The Do's and Don'ts
#363: Bringing a Self-Funded Medical Device to Market
#362: Managing Risk in Clinical Investigations
#361: Speaking the Language of IVD
#360: Is It Possible to "Buy" a QMS?
#359: Project Management in MedTech
#358: FDAs Voluntary Improvement Program
#357: The State of UDI Across the World
#356: Quality Myths & Lessons Learned Part II
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
#354: Advice for MedTech Regulatory Affairs Professionals
#353: How Artificial Intelligence is Impacting the MedTech Industry
#352: Fundamentals of Quality & Regulatory
#351: The State of AI & Clinical Investigations
#350: The Evolving Landscape of AI in MedTech
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