Natalie J. Kennel, FRAPS, RAC-US, ASQ CQE CQMg and founded NJK & Associates to bring her practical perspective to medical device quality and regulatory affairs.

With more than 35 years in industry, most devoted to medical devices, Kennel has hands-on experience with development and manufacturing as well as RA/QA and clinical roles in both major and start up medical device companies. 

Gabriela McCoole, RAC-US, is an experienced regulatory professional with over 12 years in medical  device and IVD regulatory affairs and quality management. Gabriela holds an Advanced Degree in  Molecular Biology and the Regulatory Affairs Credential (RAC - Devices).

Laura Guy, MS, RAC, earned a BS in Psychobiology from UCLA and an MS in Regulatory Affairs from SDSU. Her Company, Regulatory Liaisons, LLC provides Regulatory Affairs and Quality System services to innovators and manufacturers of pharmaceutical (Rx and OTC), biologic, cosmetic, medical devices (including IVDs) and combination products.

Kim Walker is an independent Global Regulatory, Quality, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006 with over 30 years of industry experience.  She is active in non-profits, serving on the board of directors and various committees, and has managed, moderated, and presented at several professional conferences.  

Daniel Yeh, RAC, has over ten years of experience in the Development, Manufacturing, and Commercialization of medical devices. In his current role as the Director of Regulatory and Quality at MedWaves Inc., Daniel is managing new product submissions as well as maintaining international registrations. 

Azita Hedayati is a Regulatory professional with experience in quality assurance, regulatory affairs, and program management, having spent over two decades in leadership roles within the medical device and healthcare sectors.

Olivia Yu, PhD, has extensive experience spanning exploratory drug discovery to clinical development and FDA approval. She has held various roles in preclinical research, Clinical Trial Management, Regulatory Affairs, and Project Management. 

Allison Komiyama is a Senior Regulatory Strategist at Duval & Associates with deep scientific and  entrepreneurial expertise in medical device innovation. Beyond her consulting work, Allison is engaged in  advancing regulatory education and innovation. She is the founder of Bluestocking Health, a platform  dedicated to amplifying the stories of innovative medical technologies and the people behind them. 

Tianlun Wang, PhD, RAC, is a pharmacology and regulatory affairs leader with over 25 years of experience driving global drug development for small molecules, biologics, and cell therapies.

Sarah Morache has 10 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry. Over the past decade, she has contributed to a wide range of projects with emphasis on regulatory submissions, clinical study monitoring, and the development and implementation of Quality Management Systems. 

Bree Fitzpatrick is a Regulatory and Quality Assurance professional with over eight years of experience supporting U.S. and international medical device regulatory activities.