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Christine Scifert

Founder and Partner of MRC Global

As founder and partner of MRC Global, Christine Scifert’s vision is the driving force behind the company’s continued growth. MRC Global is a regulatory and quality systems consulting firm supporting companies in the medical device industry. Scifert continues to support small and large medical device companies to identify regulatory hurdles, develop strategy, write submissions, implement quality systems, and expedite time to market while taking a risk-based approach. Scifert has been consulting for over 15 years (previously MRC-X and Memphis Regulatory Consulting). Prior to consulting, she spent nine years at Medtronic Spinal and Biologics, directing the regulatory department. As senior director, she set regulatory strategy, oversaw global submissions, and assisted in the development of a design control process. Scifert interfaced directly with the FDA and notified bodies, overseeing submissions and regulatory compliance while performing due diligence activities for potential acquisitions. Prior to Medtronic, Scifert performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents. Scifert received a Bachelor of Science in Physics from Hamline University and a Master of Science in Biomedical Engineering from the University of Iowa. She also completed a Master’s in Engineering Management from Christian Brothers University. Scifert has been an adjunct professor at Christian Brothers University, teaching regulatory affairs courses.

2:45-3:30 p.m.

Wednesday April 22, 2026

A New Era for Regulatory & QMS Requirements: An FDA & EU MDR Update

While revisions are consistently taking place across all regulatory areas, it seems recent changes have been even more impactful for medical device manufacturers. Whether the dramatic change from MDD to MDR in Europe, the FDA’s implementation of QMSR, incorporation and shifting guidance related to artificial intelligence, or an enhanced focus on testing, updated regulations, and guidance documents will have a significant impact on device makers. This session will provide a high-level overview of these changes and what they mean for the management teams in the medtech industry. Avoiding “the weeds” of regulatory minutia, attendees will find out what’s important to them and why it matters for their business.