Demystifying Quality and Regulatory

Te Tītoki Mataora | MedTech Research Translator

Interactive workshop covering quality and regulatory aspects for medical devices supported by Te Tītoki Mataora and the HealthTech Activator

Auckland Bioengineering Institute, The University Of Auckland

The next Demystifying Quality and Regulatory workshop will be taking place in person on Thursday 14th of November. This workshop is ideal for start-ups and research groups considering the commercialisation of a medical device. This workshop will help you:<ul><li>Understand the concepts involved in regulatory requirements and quality management</li><li>Explore the key parts that regulatory and quality play in the commercialisation journey for a medical device</li><li>Understand key considerations for the implementation of a regulatory strategy and quality management system</li></ul> This 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.This workshop is limited to 2 people per start-up/research group to ensure greater opportunity for others to engage. This workshop is hosted in partnership by Te Tītoki Mataora | MedTech Research Translation and the HealthTech Activator.<ul><li>If you are a researcher or a clinician, please select the Te Tītoki Mataora | MedTech Research Translation ticket. </li><li>If you are a start-up company, please select the HealthTech Activator ticket. </li></ul> Hosted by:<a href="https://www.linkedin.com/in/yaara-yarmut/" title="https://www.linkedin.com/in/yaara-yarmut/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Yaara Yarmut</a> - Chief Regulatory Officer at AlimetryYaara 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.<a href="https://www.linkedin.com/in/natalia-lopez-a34457147/" title="https://www.linkedin.com/in/natalia-lopez-a34457147/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">Natalia Lopez</a> - Chief Operations Officer at Kitea HealthNatalia’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 and was Senior Quality Manager at the Auckland Bioengineering Institute. 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).

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Demystifying Quality and Regulatory

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