Keren is a seasoned executive with more than 15 years experience in regulated industries such as medical devices, pharmaceuticals, and combination goods in quality, operations, process improvement and program management. Right now she works at Medtronic as a Quality Manager. She holds a master's degree in business administration and a bachelor's degree in biotechnology, as well as being a certified quality auditor. She organizes social and educational projects in her spare time, such as the establishment of Israel's first public Montessori school and seminars for mothers on maternity leave.
Kfar Saba, Israel
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Quality Integration in Medical Device Innovation
General, Innovation, Product
Medical devices, like all products and software, are constantly evolving. Yet, due to the nature of medical devices and their impact on personal health and safety, the entire product life cycle of a device must be carefully combined with a quality processes and documentation beginning with the initial development phase. Integrating quality via design controls process from the beginning of the development phase can help you get to market quickly with a product that meets user needs. It will also assist you in avoiding recalls, which can have a negative impact on your company's revenue and reputation. In addition, design controls will help you become more lean and agile in the later stages. This talk discusses the value of quality thinking as part of innovations and developments of medical device products, outlining the execution of design control processes and challenges so that by the end you will all be able to put it into practice.