Global Medical Device Podcast powered by Greenlight Guru
Health & Fitness:Medicine
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.
Key Timestamps1. Insights on MedTech Trends:
2. Practical Tips for MedTech Professionals:
3. Future Predictions in MedTech:
For new listeners, this episode touches upon fundamental concepts like residual risk, clinical protocol, and risk-benefit assessment in the context of medical device clinical investigations. Understanding these terms is crucial for grasping the detailed discussions of the episode.
Audience EngagementThis episode is proudly sponsored by Greenlight Guru, a leading provider of MedTech quality management & electronic data capture software. Greenlight Guru's platform is specifically designed to help medical device companies enhance the efficacy and safety of their products, ensuring they meet the stringent standards of regulatory bodies worldwide. Check out their exclusive offer for podcast listeners to streamline your quality management & data capture process.
#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
#364: Building a Partnership with your Regulatory Consultant
#363: Bringing a Self-Funded Medical Device to Market
#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
Create your
podcast in
minutes
It is Free
Good Mood Revolution
The Relaxback UK Show
On Call With Dr. Anselm Anyoha
Precision Medicine Forum Podcast
The Doctor’s Farmacy with Mark Hyman, M.D.
The Peter Attia Drive