In this episode, we’re going to talk about Postmarket Surveillance Studies.
In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.
The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device.
To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast.
David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.
David brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.
David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, and author of Mythical Medical™: Revelations from a Global Product Approval Consultant.
*
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 10,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
*
CTP 023: Clinical Research In New Zealand
CTP 022: Clinical Project Management with Antoinette (Torres) Frankum
Getting Intro Research and CRO Partnerships with Jessie Coe
CTP 020: 17 Strategies to Increase Patient Recruitment in Clinical Trials
CTP 019: Managing Clinical Inventory with Rust Felix and Joy Jurnack
CTP 018: Genetic Testing in Clinical Trials with Karmen Trzupek
CTP 017: The Ultimate Roadmap for Patient Recruitment
CTP 016: Bioethics in Clinical Research with Dr. Lindsay McNair
CTP 015: Real-World Insights and Epidemiology with Dr. Christina Mack
CTP 014: The World of Program Management with Stephen Smith
CTP 013: Become an Outstanding Clinical Researcher with Dr. Jeff Kingsley
CTP 012: Solving Clinical Research Problems Using Technology with Ryan Jones
CTP 011: From Disney to Drugs with Melissa Easy, Founder of DrugDev
CTP 010: Effective Clinical Research Sites with Gabriel D'Amico-Mazza
CTP 009: Real World Data in Clinical Trials with Manuel Prado
CTP 008: Exceptional Clinical Research Insights with Norman Goldfarb
CTP 007: The Future with EMR with Dr. Manfred Stapff
CTP 006: Journey from Engineer to Clinical Director with Robin Eckert
CTP 005: Health Economics and Outcomes Research with James Hasegawa
CTP 004: 13 Suggestions for Becoming a Great Clinical Project Manager
Create your
podcast in
minutes
It is Free
The Commercial Edge: Unleash the Power of People
The emPOWERed Half Hour
Reaching your Goals
Insights@work
The Wall Street Skinny
The Ken Coleman Show
Business Dad