Device Advice by RQM+
By RQM+
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Subscribers: 6
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Episodes: 194
Description
RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing.
RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties.
Please visit RQMplus.com to learn more.
| Episode | Date |
|---|---|
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Live! #87 – Built for Her: Funding, fixing, and fueling the next era of MedTech
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Apr 08, 2025 |
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Breast Cancer Panel, Part 3: MedTech Innovations
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Apr 07, 2025 |
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Breast Cancer Panel, Part 2: Treatment and Advocacy
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Apr 05, 2025 |
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Breast Cancer Panel, Part 1: Diagnosis and Personal Journeys
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Apr 04, 2025 |
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Weekly Watch #51 (AI-Generated, Subscribe On LinkedIn)
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Apr 02, 2025 |
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Weekly Watch #48 (AI-Generated, Subscribe On LinkedIn)
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Mar 11, 2025 |
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Celebrating the Women Who Inspire Us 💜
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Mar 10, 2025 |
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Weekly Watch #47 (AI-Generated, Subscribe On LinkedIn)
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Mar 06, 2025 |
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Live! #86 – PART 2: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD
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Feb 12, 2025 |
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Live! #85 – Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD
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Dec 19, 2024 |
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Live! #84 – Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework
|
Dec 05, 2024 |
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Chris Parr, Principal Consultant | Excellence Spotlight
|
Nov 14, 2024 |
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Carrie Schneider, Principal Consultant | Excellence Spotlight
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Nov 07, 2024 |
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What makes a successful regulatory submission from a clinical trial perspective for IVDs? – MedTech CRO: Regulatory Expertise Series
|
Nov 04, 2024 |
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Holly Cotter, Senior Consultant | Excellence Spotlight
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Oct 28, 2024 |
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What makes a successful regulatory submission from a clinical trial perspective? (Part 3/3) – MedTech CRO: Regulatory Expertise Series
|
Oct 22, 2024 |
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Live! #83 – Structured Dialogue: How to Engage with Notified Bodies
|
Oct 17, 2024 |
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What makes a successful regulatory submission from a clinical trial perspective? (Part 2/3) – MedTech CRO: Regulatory Expertise Series
|
Oct 15, 2024 |
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Christine Anderson, Principal Consultant | Excellence Spotlight
|
Oct 14, 2024 |
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What makes a successful regulatory submission from a clinical trial perspective? (Part 1/3) – MedTech CRO: Regulatory Expertise Series
|
Oct 10, 2024 |
|
Michael Louis, Chemist II (Jordi Labs) | Excellence Spotlight
|
Oct 08, 2024 |
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Best Practices In AE Reporting In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
|
Oct 02, 2024 |
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Effective and Efficient Safety Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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Sep 26, 2024 |
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Live! #82 – MDR and IVDR Amendments: Strategies for Supply Interruption Compliance
|
Sep 26, 2024 |
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Anthony Grice, Chemist III (Jordi Labs) | Excellence Spotlight
|
Sep 25, 2024 |
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Craig Young, Lab Coordinator (Jordi Labs) | Excellence Spotlight
|
Sep 16, 2024 |
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Michael Morales, Chemist II (Jordi Labs) | Excellence Spotlight
|
Sep 12, 2024 |
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How a CRO Helps with Data Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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Sep 11, 2024 |
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Tommy Kumlin, Chemist I (Jordi Labs) | Excellence Spotlight
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Sep 04, 2024 |
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Data Management In Clinical Trials (Maintenance/Closeout) – MedTech CRO: Clinical Trial Execution Series
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Sep 03, 2024 |
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Data Management In Clinical Trials (Setup Phase) – MedTech CRO: Clinical Trial Execution Series
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Aug 28, 2024 |
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Joshua Nott, Technical Program Lead (Jordi Labs) | Excellence Spotlight
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Aug 27, 2024 |
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Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2) – MedTech CRO: Clinical Trial Execution Series
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Aug 16, 2024 |
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Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2) – MedTech CRO: Clinical Trial Execution Series
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Aug 15, 2024 |
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Live! #81 (with FDA) – Advancing Health Equity with IVDs & Medical Devices
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Aug 14, 2024 |
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Tactical Considerations for IVD Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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Aug 06, 2024 |
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Site Monitoring In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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Aug 02, 2024 |
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Site Selection In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
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Jul 31, 2024 |
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Live! #80 – Beyond EtO: New EPA Regulations and Sterilization Alternatives
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Jul 18, 2024 |
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Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise Series
|
Jul 17, 2024 |
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RQM+ Consultant Roundtable
|
Jul 16, 2024 |
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Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series
|
Jul 11, 2024 |
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Key Aspects of Medical Device Clinical Trial Design (2/2) – MedTech CRO: Strategy Development Series
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Jul 08, 2024 |
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Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment
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Jul 05, 2024 |
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Key Aspects of Medical Device Clinical Trial Design (1/2) – MedTech CRO: Strategy Development Series
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Jul 01, 2024 |
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Risk Management In Clinical Trials – MedTech CRO: Strategy Development Series
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Jun 27, 2024 |
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Would you like to get reimbursed? – MedTech CRO: Strategy Development Series
|
Jun 25, 2024 |
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Tactics for Global Pivotal Studies – MedTech CRO: Clinical Trial Execution Series
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Jun 20, 2024 |
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Strategy for Global Pivotal Studies – MedTech CRO: Strategy Development Series
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Jun 18, 2024 |
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Tactics for First-in-Human Studies – MedTech CRO: Clinical Trial Execution Series
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Jun 12, 2024 |
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Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series
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Jun 10, 2024 |
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Live! #79 – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut
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Jun 07, 2024 |
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Strategy for First-in-Human Studies (1/2) – MedTech CRO: Strategy Development Series
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Jun 05, 2024 |
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Teaser: Introducing Our Clinical Trials Educational Video Series
|
Jun 03, 2024 |
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Scott Edwards, Managing Director | Excellence Spotlight
|
May 08, 2024 |
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Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan
|
May 01, 2024 |
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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices
|
Apr 30, 2024 |
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Samantha Howard, Study Director (Jordi Labs) | Excellence Spotlight
|
Apr 29, 2024 |
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Noel Keegan on Clinical Data Management | Excellence Spotlight Bonus
|
Apr 19, 2024 |
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Nancy Morrison's Keys to Thriving in Regulatory Affairs: Lessons Learned from a 30+ Year Career
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Apr 12, 2024 |
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Live! #77 – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
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Apr 10, 2024 |
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Sew-Wah-Tay, Vice President of Strategic Regulatory Affairs | Excellence Spotlight
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Apr 04, 2024 |
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How does a notified body clinical reviewer approach a review? | MedTech Voices
|
Apr 01, 2024 |
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Adam Eason, Senior Study Director (Jordi Labs) | Excellence Spotlight
|
Mar 26, 2024 |
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Noel Keegan, Sr. Director, Data Operations (Clinical Trials) | Excellence Spotlight
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Mar 21, 2024 |
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Kaitlin Lerner, Director of Operations, Lab Services (Jordi Labs) | Excellence Spotlight
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Mar 13, 2024 |
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Anastassia Young, Senior Consultant | Excellence Spotlight
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Mar 05, 2024 |
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Streamlining AE Reporting in PMCF Studies (FDA Perspective) | MedTech Voices
|
Mar 04, 2024 |
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Live! #76 – MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices
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Feb 29, 2024 |
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Song Seto, Principal, Regulatory and Quality Practice | Excellence Spotlight
|
Feb 27, 2024 |
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The Expansion of AI in In Vitro Diagnostics | MedTech Voices
|
Feb 20, 2024 |
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Taryn Meade, Director of Biological Evaluation Consulting | Excellence Spotlight
|
Feb 19, 2024 |
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An MDCG 2023-7 Summary (🎟️ RSVP for our Feb. 22 expert panel) | MedTech Voices
|
Feb 15, 2024 |
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Insights on FDA Approval and Future Challenges for Transcatheter Tricuspid Valve Replacement Devices | MedTech Voices
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Feb 14, 2024 |
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Garrett Jeffries, Principal, Clinical and Post-Market Practice | Excellence Spotlight
|
Feb 13, 2024 |
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Elizabeth Starling, Senior Consultant | Excellence Spotlight
|
Feb 06, 2024 |
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EU MDR Expert Panel Feedback (#11) | MedTech Voices
|
Feb 05, 2024 |
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Laurie Pettit, Senior Manager, RA/QA Consulting Services | Excellence Spotlight
|
Jan 30, 2024 |
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What makes a good EU MDR program from a maintenance perspective? | MedTech Moments
|
Jan 29, 2024 |
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Nicholas Wilson, Principal, Clinical and Post-Market Practice | Excellence Spotlight
|
Jan 26, 2024 |
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The Proposed Amendments to MDR and IVDR | MedTech Voices
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Jan 24, 2024 |
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Live! #75 – Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers
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Jan 22, 2024 |
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Alexia Haralambous, Senior Principal | Excellence Spotlight
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Jan 10, 2024 |
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Niki Caporali Spaniel, Principal, CPMP, Practice Manager | Excellence Spotlight
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Jan 02, 2024 |
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Lindsay Wright, Senior Consultant / Capability Manager | Excellence Spotlight
|
Dec 20, 2023 |
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Blood Pressure Control via Renal Denervation: Knowns vs. Unknowns | MedTech Voices
|
Dec 19, 2023 |
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Rostislav Stoykov, Principal RA/QA | Excellence Spotlight
|
Dec 12, 2023 |
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A PFAS Primer (🎟️ RSVP for our Jan. 18th expert panel) | MedTech Voices
|
Dec 11, 2023 |
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Live! #74 – A New Era of LDT Oversight: Adapting to FDA Regulations
|
Dec 05, 2023 |
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Torrie DeGennaro, Principal | Excellence Spotlight
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Dec 04, 2023 |
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Richard Freeman, Director of Global Audit Practice | Excellence Spotlight
|
Nov 29, 2023 |
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Andrew Lakey, Senior Consultant | Excellence Spotlight
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Nov 21, 2023 |
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Brandy Chittester, Senior Director of Clinical Operations | Excellence Spotlight
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Nov 15, 2023 |
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Hrishikesh Gadagkar, Senior Principal Engineer | Excellence Spotlight
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Nov 07, 2023 |
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EU MDR Expert Panel Feedback (#10) | MedTech Voices
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Nov 06, 2023 |
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Cari Kniola, Senior Director of Project Management | Excellence Spotlight
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Nov 01, 2023 |
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Live! #73 – October Overview: Essential Insights from an Eventful Month in MedTech
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Oct 27, 2023 |
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Ethan Elshoff, Senior Project Manager | Excellence Spotlight
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Oct 19, 2023 |
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Catherine Kang, Principal Consultant | Excellence Spotlight
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Oct 10, 2023 |
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EU MDR Expert Panel Feedback (#9) | MedTech Voices
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Oct 05, 2023 |
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Kevin Rowland, Director of R&D | Excellence Spotlight
|
Oct 02, 2023 |
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Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance
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Sep 28, 2023 |
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Diane Cox, Principal Consultant | Excellence Spotlight
|
Sep 26, 2023 |
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Live! #71 – Material Matters: Navigating Risks and Strategies for Improving Medical Device Safety
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Sep 22, 2023 |
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EU MDR Expert Panel Feedback (#8) | MedTech Voices
|
Sep 11, 2023 |
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Pooja Roychoudhury, Senior Principal Engineer | Excellence Spotlight
|
Sep 06, 2023 |
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Live! #70 – IVDR Class D Devices: Advanced Strategies for Succeeding In a Dynamic Regulatory Environment
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Sep 01, 2023 |
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BONUS Excellence Spotlight with Case Studies — Jon Gimbel, Vice President of Technical
|
Aug 22, 2023 |
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EU MDR Expert Panel Feedback (#7) | MedTech Voices
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Aug 15, 2023 |
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Amie Smirthwaite's Role in ISO 18969 | MedTech Voices
|
Aug 08, 2023 |
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Bethany Chung, Principal Regulatory Scientist | Excellence Spotlight
|
Aug 03, 2023 |
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Live! #69 – Insider Perspectives: Mastering EU Compliance with BSI's Richard Holborow and RQM+'s Amie Smirthwaite
|
Jul 28, 2023 |
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EU MDR Expert Panel Feedback (#6) | MedTech Voices
|
Jul 26, 2023 |
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Live! #68 – Pre-Submission to Preeminence: Showcasing FDA's Latest Pre-Sub Guidance and Uncovering PCCP Best Practices
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Jul 25, 2023 |
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Jon Gimbel, Vice President of Technical | Excellence Spotlight
|
Jul 19, 2023 |
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Eila Pattee, Principal Consultant | Excellence Spotlight
|
Jul 07, 2023 |
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EU MDR Expert Panel Feedback (#5) | MedTech Voices
|
Jun 28, 2023 |
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EU MDR Expert Panel Feedback (#4) | MedTech Voices
|
Jun 02, 2023 |
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Live! #67 – Beyond Indications: Managing Off-Label Use for Safety and Compliance
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May 25, 2023 |
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Live! #66 – Pragmatic and Compliant Approaches to Clinical Evidence
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Apr 28, 2023 |
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EU MDR Expert Panel Feedback (#3) | MedTech Voices
|
Apr 03, 2023 |
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Traversing the Path from CER to PMCF (#2) | MedTech Voices
|
Mar 28, 2023 |
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Traversing the Path from CER to PMCF (#1) | MedTech Voices
|
Mar 27, 2023 |
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Live! #65 – How AI is Revolutionizing MedTech: Current and Future Applications
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Mar 24, 2023 |
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Live! #64 – The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory Requirements
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Feb 17, 2023 |
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Live! #63 – Start 2023 Right: Smart and Savvy Tips from Former Regulators and Notified Bodies
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Jan 27, 2023 |
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Proactive PMCF Data with Economy and Expediency (#3) | MedTech Voices
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Jan 23, 2023 |
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Proactive PMCF Data with Economy and Expediency (#2) | MedTech Voices
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Jan 18, 2023 |
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MDCG Proposal for EU MDR Postponement – The Latest on What's Next
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Jan 06, 2023 |
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Proactive PMCF Data with Economy and Expediency (#1) | MedTech Voices
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Dec 13, 2022 |
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EU MDR Postponed – What We Know Now and What's Next
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Dec 09, 2022 |
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EU MDR Expert Panel Feedback (#2) | MedTech Voices
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Dec 01, 2022 |
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EU MDR Expert Panel Feedback (#1) | MedTech Voices
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Nov 17, 2022 |
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Live! #62 – Standards and State of the Art (SOTA)
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Nov 08, 2022 |
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Live! #61 – Medical Device Software: Top Deficiencies and Requests for Additional Info from FDA and Notified Bodies
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Oct 14, 2022 |
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Live! #60 – RAPS Convergence Takeaways: RQM+ event speakers share their biggest surprises and learnings
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Sep 26, 2022 |
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Live! #59 – Clinical Evidence vs. Clinical Performance – A Deep Dive into MDCG 2022-2 and Notified Body Expectations
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Jul 22, 2022 |
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Live! #58 –Regulatory Landscape of Companion Diagnostics (CDx) in the EU
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Jul 15, 2022 |
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Live! #57 – FDA Appeals Process (featuring panelists from Linear Health and DuVal & Associates, PA)
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Jun 30, 2022 |
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Live! #56 – IVDR: A Notified Body Perspective (featuring Marta Carnielli of TÜV SÜD)
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Jun 13, 2022 |
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Live! #55 – Is your labeling thrice as big as your device yet?
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May 24, 2022 |
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Live! #54 – Implications of FDA Adopting ISO 13485 and How to Prepare
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May 24, 2022 |
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Live! #53 – Part 2: PSURs – Ready, Set, Go!
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Apr 26, 2022 |
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Live! #52 – Part 2: What’s new in the world of biocompatibility for medical devices?
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Apr 11, 2022 |
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Live! #51 – Leveraging your medical directors and clinicians for successful regulatory submissions
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Mar 29, 2022 |
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Live! #50 – IVDR Notified Body Application Process
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Mar 14, 2022 |
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RQM+ Live! #49 — PSURs – Ready, Set, Go!
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Mar 01, 2022 |
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RQM+ Live! #48 — Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
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Feb 15, 2022 |
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RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong?
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Jan 31, 2022 |
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RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA Submissions
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Jan 18, 2022 |
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RQM+ Live! #45 — What’s new in the world of biocompatibility for medical devices?
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Jan 06, 2022 |
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RQM+ Live! #44 — Success Stories of PMCF Surveys: Strategy and Execution
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Dec 03, 2021 |
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RQM+ Live! #43 — Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24
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Nov 11, 2021 |
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Live! #41 — Best Practices for Optimizing PMCF and Avoiding NB Findings
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Oct 15, 2021 |
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Live! #40 — When should we throw the least burdensome flag or appeal an FDA decision?
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Oct 01, 2021 |
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Live! #39 — Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
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Aug 27, 2021 |
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Live! #38 — Best Practices in Site Transfer (or Consolidation)
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Jul 23, 2021 |
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Live! #37 — U.S. FDA Pathways for Innovative Devices
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Jun 18, 2021 |
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Event Recording — FDA Submissions in 2021: How's it going?
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Jun 09, 2021 |
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Live! #36 — Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2!
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Jun 03, 2021 |
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Live! #35 — Preparing for PSURs
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May 20, 2021 |
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Live! #34 — Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)
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May 06, 2021 |
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Live! #33 — Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions
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Apr 23, 2021 |
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Live! #32 — What if I'm not ready for EU MDR on May 26, 2021?
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Apr 08, 2021 |
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Live! #31 — Biological Equivalence Demystified
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Mar 26, 2021 |
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Live! #30 — IVD Intended Purpose Statements – Defining for Success
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Mar 11, 2021 |
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Live! #29 — The surprising true cost of submitting non-compliant technical documentation to notified bodies
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Feb 25, 2021 |
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Live! #28 — Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR
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Feb 12, 2021 |
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Live! #27 — 2021 Outlook on FDA Submissions
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Jan 28, 2021 |
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Live! #26 — What is the Biggest EU MDR or IVDR Question You Need to be Answered?
|
Jan 15, 2021 |
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Live! #25 — Is ISO 14971:2019 required under MDR/IVDR?
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Dec 21, 2020 |
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Live! #24 — Generating Sufficient Clinical Evidence for IVDs
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Dec 04, 2020 |
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Live! #23 — Make real world evidence work for you: How to leverage real world data in the US and EU
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Nov 24, 2020 |
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Live! #22 — Summary of Safety and Clinical Performance
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Nov 06, 2020 |
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Live! #21 — Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys
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Oct 23, 2020 |
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Live! #20 — Commercializing Medical Devices in a Post-Brexit World
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Oct 12, 2020 |
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Live! #19 — The most popular PMCF and PMPF questions from our clients
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Sep 29, 2020 |
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Live! #17 — Periodic Safety Update Report: How do you write it without guidance?
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Sep 11, 2020 |
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Live! #16 — Creating Performance Evaluation Plans and Reports under the IVDR
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Aug 31, 2020 |
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Live! #15 — When to use the FDA Q-Submission (Pre-Sub) Program
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Aug 14, 2020 |
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Live! #14 — Is your device a Well-Established Technology (WET) under EU MDR?
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Jul 31, 2020 |
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Live! #13 — Is this software application a medical device?
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Jul 17, 2020 |
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Live! #12 — Tips and Tricks for a Smooth 510(k) Process
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Jul 06, 2020 |
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Live! #11 — I don't have clinical data for my device. What are my options for fulfilling the sufficient clinical evidence requirements under EU MDR?
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Jun 25, 2020 |
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Live! #10 — Transition to IVDR: How far along should we be?
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Jun 18, 2020 |
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Live! #9 — Experiences with the FDA 3rd Party 510(k) Review Program
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Jun 11, 2020 |
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Live! #8 — FDA Trends: Inspections and Submissions
|
Jun 04, 2020 |
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Live! #7 — Getting Legacy Device Risk Files Ready for EU MDR / ISO 14971:2019
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May 28, 2020 |
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Live! #6 — PMCF Process in Action: Best Practices for MDR Compliance
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May 22, 2020 |
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Live! #5 — Chatting with Former FDA and Notified Body Representatives
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May 15, 2020 |
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Live! #4 — Best Practices for Easing the Burden of a Medical Device Remediation Program
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May 12, 2020 |
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Live! #3 — Recent MDD and MDR Audit Findings: What are we seeing?
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May 12, 2020 |
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Live! #2 — Use of FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for COVID-19 Public Health Emergency
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May 12, 2020 |
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Live! #1 — Moving medical device manufacturing out of China
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May 12, 2020 |