Advanced Manufacturing 2017 Schedule Viewer

Marcelo Trevino, Senior Director, Quality and Regulatory Affairs, Nihon Kohden America

Marcelo Trevino is an Experienced Senior Director with Nihon Kohden America, one of the fastest growing manufacturers of Patient Monitoring equipment in the U.S. with a large global footprint. Marcelo directs the Quality and Regulatory Affairs initiatives at the Corporate Headquarters in Irvine, CA. The product lines include Enterprise Patient Monitoring as well as Neurology and Cardiology equipment. Prior to Nihon Kohden America, Marcelo led Quality Systems and Regulatory Compliance initiatives for several years as a Senior Manager at Medtronic's Heart Valve manufacturing Center of Excellence.

Mr. Trevino has an extensive knowledge of medical device management systems (ISO 13485:2003) and international medical device regulations for the United States (FDA QSR), Australia (Therapeutic Goods, Medical Devices Regulations), Canada (SOR/98-282 and Canadian Medical Devices Conformity Assessment System), Japan (Pharmaceutical Affairs Law), and Europe (93/42/EEC Medical Device Directives). He holds a B.S. degree in Industrial and Systems engineering from ITESM in Mexico and an MBA in Supply Chain Management from the W.P. Carey School of Business at Arizona State University. He is also a certified Quality Management Systems Lead Auditor by Exemplar Global and has consulted with several corporate executives in medical device firms to implement different process and quality improvement projects. Additionally, he is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ) and holds Certificates in Environmental & Sustainability Management Regulatory Affairs Management from University of California, Irvine.

Marcelo has experience working on Lean Six Sigma Projects and many Quality/Regulatory Compliance initiatives the medical device industry in the US and around the world. He has conducted Third Party Audits and has written several articles to assist corporations in their quest for quality and service excellence.

Presenting:

• Transitioning to the New Standard: Are You Struggling with ISO 13485?
• Strategies for Conducting a Robust Gap Assessment for ISO 13485