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Device Advice: A Podcast by RQM+
RQM+ industry-leading experts discuss timely regulatory and quality topics medical device, IVD, and combination product companies are facing.
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PSURs – Ready, Set, Go!
Listen to our panel as they elaborate on successes, failures, and notified body feedback they've experienced so far.
Duration: 48:16 -
Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
What does life look like for regulatory, clinical, quality, and PMS functions as we enter MDR/IVDR sustaining mode?
Duration: 46:42 -
Have we been looking at EU MDR equivalence requirements all wrong?
A new perspective on the equivalence requirements of EU MDR Article 61 and more.
Duration: 53:28 -
Year-end Review and 2022 Outlook on FDA Submissions
A recap of important FDA regulatory changes in 2021 and a forecast of what's to come in 2022. Join our former FDA CDRH experts!
Duration: 52:17 -
What’s new in the world of biocompatibility for medical devices?
Changes to standards in recent years, what’s on the horizon for 2022, answers to common questions, and more!
Duration: 49:42 -
Success Stories of PMCF Surveys: Strategy and Execution
Hear from the expert RQM+ team leading survey projects.
Duration: 50:08 -
Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24
Join industry's leading experts, including recent notified body leaders and medical experts, for a discussion of solutions and next steps you'll want to consider.
Duration: 54:16 -
Unearthing IVDR with Former Notified Body Leader, Carlos Galamba
Hear directly from a technical manager who helped develop BSI's IVDR program.
Duration: 56:19 -
Best Practices for Optimizing PMCF and Avoiding NB Findings
Learn from our experts as they share PMCF successes and failures they've seen so far.
Duration: 51:27 -
When should we throw the least burdensome flag or appeal an FDA decision?
What’s the best approach to get the results you desire while not becoming FDA’s arch nemesis?
Duration: 38:31 -
Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
What does life look like for regulatory, clinical, quality, and PMS functions as we enter MDR/IVDR sustaining mode?
Duration: 44:50 -
Best Practices in Site Transfer (or Consolidation)
RQM+ subject matter experts share case studies, lessons learned, and best practices.
Duration: 40:10
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