Where do you start? How do you know your device qualifies? Join our panel with RQM+ FDA experts.Duration: 39:15
This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021.Duration: 51:53
Learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day.Duration: 43:17
Processes, templates, efficiencies, and other best practices for all things PSURs.Duration: 44:43
Our panelists have created a significant amount of MDD and MDR technical documentation files. Listen to hear their strategies!Duration: 55:02
Learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day.Duration: 51:40
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
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