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X-WR-CALDESC:Events for Tech New Zealand
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DTSTART;TZID=Pacific/Auckland:20230503T090000
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SUMMARY:Demystifying Quality and Regulatory
DESCRIPTION:The next Demystifying Quality and Regulatory workshop will be taking place in-person on Wednesday 3rd of May. This workshop is ideal for start-ups and research groups considering the commercialisation of a medical device. \nThis workshop will help you: \n\nUnderstand the concepts involved in regulatory requirements and quality management\nExplore the key parts that regulatory and quality play in the commercialisation journey for a medical device\nUnderstand key considerations for the implementation of a regulatory strategy and quality management system\n\nThis will be an interactive workshop with opportunities to break out into groups to work on real world examples. So come ready to participate and put into practice what is learned along the way. \nThis workshop is limited to 2 people per start-up/research group to ensure greater opportunity for others to engage. \nHosted by: \nYaara Yarmut – Chief Regulatory Officer at Alimetry \nYaara started her career as a vet\, before making a shift and joining the medical device industry. Yaara has worked as Regulatory\, Quality and Clinical Manager for multiple Israel-based start-ups in areas including cardiology\, surgery and cancer diagnostics. Yaara specializes in the development of regulatory strategies and leading regulatory submissions to FDA and EU\, as well as the product development lifecycle\, and clinical trials. She is currently the Chief Regulatory Officer for Alimetry\, a company developing non-invasive diagnostic solutions for GI functional disorders. Yaara holds a BSc. in life sciences and a Doctor of Veterinary Medicine. \nNatalia Lopez – Senior Quality Manager at the Auckland Bioengineering Institute \nNatalia’s career started off in the heavily regulated automotive industry as a system’s engineer. This complimented her shift into the life science and medical device industry 10 years ago where she designed and implemented quality management systems. She has worked with multiple medical device spinouts to develop their quality systems and to ensure regulatory compliant product development. She was previously the Chief Operating Officer for Kaha Sciences\, a wireless telemetry solutions company. She is now working with the ABI’s Implantable Devices Group on market entry strategy for a novel medical device. Natalia holds a Bachelor of Science Electrical Engineering from Louisiana Tech University (US) and a Postgraduate Diploma in Quality Systems Design from Massey University (NZ).
URL:https://technewzealand.org.nz/event/demystifying-quality-and-regulatory/
LOCATION:Auckland Bioengineering Institute\, Auckland Bioengineering Institute\, The University Of Auckland 70 Symonds Street #6 Auckland\, Auckland 1010
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