Learn effective strategies for staying on the market as long as possible while remaining compliant.Duration: 49:12
Our panel discusses solutions for establishing successful biological equivalence rationales.Duration: 52:11
Strategies for developing statements, evidence, and a compelling story tying it all together.Duration: 36:50
MDR requires much greater transparency of information, as evidenced by requirements such as SSCP, and this will require public disclosure of evidence that manufacturers may previously have considered confidential.Duration: 49:12
Our experts discuss how the data inputs and outputs for these documents are interrelated and provide guidance and best practices on how to share information throughout the organization to streamline processes and ensure consistency.Duration: 56:57
Our panel of regulatory experts, including former FDA CDRH representatives, discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines.Duration: 41:47
In this unique episode of RQM+ 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.Duration: 36:05
The panel discusses changes in the 2019 edition of ISO 14971, areas of notified body focus, and topics of confusion or debate.Duration: 37:51
Our panel of experts will discuss what performance evaluation, scientific validity, analytical performance and clinical performance are for IVDs, the steps to generating data that will be accepted by the notified bodies, and our lessons learned so far.Duration: 33:18
Determining what RWD and RWE are and how to apply them for your device can be daunting. In this show, we will simplify these terms and discuss best practices (and much more).Duration: 37:32
RQM+ has submitted multiple SSCPs and received notified body feedback. Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.Duration: 37:24
Our experts discuss circumstances when PMCF surveys are an appropriate PMCF activity and more.Duration: 40:37
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