This is the audio-only version of DEVICE LOVE Live! #26, originally recorded January 14, 2021.
In this unique episode of DEVICE L❤️VE Live!, the focus turns to Dr. Amie Smirthwaite, Head of Clinical Regulatory Affairs at RQM+, as she answers questions from our recent EU MDR and IVDR email survey. Amie will be covering a multitude of areas, including legacy products, CERs, PMCF, PSURs, and notified body/commission commentary.
Want to learn more about Amie? Her lengthy credentials are listed below! Please join us this Thursday at 11am ET by registering below, and hear her answers... and have a chance to ask a question of your own.
Former Global Head of Clinical compliance for BSI Notified Body. Built clinical compliance team and lead clinical aspects of successful MDR designation; also significant contributor to successful IVDR designation on performance evaluation requirements A recent contributor to European Commission Clinical Investigations and Evaluations Expert Group, include subgroups which authored the following guidance documents: MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies
MDCG 2020-5 Guidance on clinical evaluation – Equivalence
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-7 Guidance on PMCF plan template
MDCG 2020-8 Guidance on PMCF evaluation report template
MDCG 2020-13 Clinical evaluation assessment report template
MDCG 2020-x (not yet published) Guidance on PSUR Contributor to an expert panel on how to assess novelty in medical devices, and SCHEER consultation on phthalates in medical devices Member of ISO technical committees 194 (Biological and clinical evaluation of medical devices) and 150 (Implants for surgery), a contributor to ISO 14155 and new proposals for clinical evaluation standards
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