Demystifying Quality and Regulatory

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.

This workshop will help you:

• Understand the concepts involved in regulatory requirements and quality management
• Explore the key parts that regulatory and quality play in the commercialisation journey for a medical device
• Understand key considerations for the implementation of a regulatory strategy and quality management system

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.

Hosted by:

Yaara Yarmut – Chief Regulatory Officer at Alimetry

Yaara 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.

Natalia Lopez – Senior Quality Manager at the Auckland Bioengineering Institute

Natalia’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).

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