Christine Scifert, M.S., M.E.M.
Prior to consulting, Christine spent 9 years at Medtronic Spinal and Biologics directing the regulatory department of 22 people. As Senior Director of the group, she set regulatory strategy, oversaw global submissions, developed a design control process, interfaced with FDA and notified bodies, oversaw modification and implementation of procedures to maintain regulatory compliance and performed due diligence activities for potential acquisitions. Prior to Medtronic, she performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents.
Christine received a Bachelor of Science in Physics from Hamline University and a Masters of Science in Biomedical Engineering from University of Iowa. She also completed a Masters in Engineering Management from Christian Brothers University.
Dawn Norman, M.S.
Before joining MRC X, LLC in 2014, Dawn spent 15 years in the medical device industry working with venture capital backed start-ups and larger companies alike. She focused on regulatory strategy and submissions, along with clinical study design and study execution, for products such as, magnetic navigation devices for neurosurgical, neurovascular and cardiac indications, high intensity ultrasound for cardiac ablation, recombinant proteins for bone fusion, orthopedic trauma and imaging technologies.
Dawn received a Bachelor of Arts in Biological Sciences and Chemistry, and a Masters of Science in Biomedical Sciences from Southern Illinois University at Edwardsville.
Machelle Shields, MBA, CMPE, CHC, CHPC, CHRC, CCS-P, CPC, CPC-H
With over 15 years of experience, Machelle focuses her practice on compliance and regulatory services for life science companies, including device/technology reimbursement strategy (coding coverage and payment), the infrastructure needs of start-up device companies and all aspects of compliance program design, operation, and implementation across the healthcare spectrum – physicians, hospitals, Medicare Advantage, device, pharmaceutical companies and other healthcare providers.
Machelle also has the unique experience of having served as a Federal Monitor team lead for a device company’s deferred prosecution agreement and as a VP/CCO for a fortune 500 company.
In addition to her undergraduate degrees and MBA, Machelle maintains three nationally recognized compliance certifications (compliance, privacy and research) and three nationally recognized coding certifications. She also holds a graduate certificate in pharmaceutical and medical device law and compliance and is currently pursuing a Master of Science in Jurisprudence.