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
This session will contain critical information for any decision-makers doing business in the UK or Europe in the continually turbulent post-Brexit world.Duration: 26:13
Will what I have be enough or am I planning for too much? How do I get the functions aligned... PMS, regulatory, risk, clinical, and marketing? Our panel answers these questions and more.Duration: 32:43
The requirements in the regulation are new and seem to overlap with existing reports. We have yet to see any specific guidance or the PSUR template rumored to be in development and if SSCP and PMCF are any indication, it will be extensive. Where does that leave the industry on how far to go with data and analysis in the initial PSUR, what will be good enough to satisfy the notified bodies? Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.Duration: 39:34
Our panel discusses strategies and best practices for developing PEP's and PERs.Duration: 40:02
FDA submission experts, including recent CDRH staff, discuss when to use the pre-sub process, real and perceived risks associated with the process, tips and tricks to achieving a successful meeting, and case studies of our experiences.Duration: 32:33
In this show, we provide our current thinking on the WET debate and some tips for interacting with your notified body.Duration: 32:41
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