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Mayo Clinic Innovation Exchange
FDA Regulatory Process and Approval Strategy (Regulatory 101)
Attend this event for an overview, presented by MRC Global, of the FDA regulatory submission and approval process for devices and drugs . You’ll learn about the need for a regulatory strategy, FDA device classifications, and design control and quality management systems.

Topics will include: global regulatory assessment, planning and strategy; traditional and special 510(k), pre-market approval (PMA) and de novo preparation and submission; European technical file and design dossier preparation; quality system management; design controls; risk management; predicate devices; and usability.

Jul 23, 2020 12:00 PM in Eastern Time (US and Canada)

Mayo Clinic Innovation Exchange
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Speakers

Christine Scifert
Executive Vice President @MRC Global LLC
Christine Scifert is executive vice president of MRC Global LLC. The company provides a comprehensive solution for regulatory, quality or clinical consulting needs for medical devices, biologics and tissue companies. Services also include thought-leadership and classification/compensation for Key Opinion Leaders and access to an expanded suite of strategic, financial, transaction, compliance and operational support services to pharmaceutical and medical device companies, hospitals, health systems, ASCs and medical practices.