Resources – Quality

 

 

Quality

Kristin Mortenson 

The foundation for bringing medical products to market began with a Bachelor of Mechanical Engineering, from the University of Minnesota Twin Cities, and continues to this day with ~30 years of industry experience and continuing education. The combined experience bridges across Research, Design, Development, Quality, and Regulatory through a broad range of products and companies ranging from small to large multi-national. Specializing in start ups, and using project management practices for product development, utilizing design control steps and integrated risk management.

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Anne Quinlan-Smith

Is the Sr. Vice President of Quality, Regulatory and Clinical Affairs at Surgical Information Sciences. Anne is an experienced Division President with a demonstrated history of working in the medical device industry. She is a strong business development professional skilled in U.S. Food and Drug Administration (FDA), Clinical Research, Medical Devices, Life Sciences, and CRO Management. Anne understands corporate goals to plan practical regulatory strategies, and has experience developing clinical study designs to collect clinical evidence and reimbursement data supportive of regulatory and reimbursement strategies. She can help you budget for clinical, regulatory and quality costs and prepare for meetings with Regulatory Agencies.

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