Mary Wentorf
principal regulatory & quality consultant
Mary Wentorf is the Owner of Springboard Medical Device Consulting, LLC. Mary brings boundless energy and over 24 years of global experience developing cardiovascular & orthopedic medical devices. With a B.S. in Mechanical Engineering from the University of Minnesota, Mary has held various leadership roles in new product development, marketing, regulatory, quality, operations, clinical application engineering, and business development. Mary is honored to have lead the development of many implants, instruments, sterilization cases, sterile packaging configurations, and medical device software, holding over 40 patents (multiple filed globally for a total of 118). She is an expert in the development of total joints (hips, knees, shoulders) with a specialization in revision and endoprostheses, trauma and deformity correction (long bones, hand/foot, hardware and software), pacemaker/defibrillator leads with a specialization in heart failure therapies, catheters, single use and reusable surgical instruments, and sterilization cases. She is currently gaining experience in neurological drug delivery, small bore connectors, and pre-filled syringes.
Most recently, Mary served as Chief Technology Officer at a start-up specializing in orthopedic medical devices for children where she was responsible for building product development, quality, and regulatory departments as well as responsibilities for surgeon compliance/relationship management and business development. Having worked at companies of all sizes, Mary is passionate about helping clients solve problems, navigate design controls, apply risk management principles, and bring products to market quickly with high quality standards.
Common requests from clients include training and consulting on design controls and risk management; QMS establishment and optimization; regulatory strategy, pre-submission facilitation, and submission writing (US FDA and EU MDR); sterile packaging design and process validation strategy; post market surveillance set-up and optimization; design assessment and strategic recommendations; and business development strategy. Mary lives in Warsaw, Indiana with her husband, two boys, and two dogs where she is an amateur backyard adventure enthusiast, elementary school Lego Robotics Instructor, as well as an advisor and guest lecturer for the Grace College Engineering Department.
For more information, please see her LinkedIn profile.