Marcelo Trevino is a Global Vice President of Regulatory Affairs and Quality Assurance at Agendia, a leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions.
Mr. Trevino has over 23 years of experience in Quality and Regulatory Affairs in multiple senior leadership roles with different organizations managing a wide variety of medical devices. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDD/MDR, MDSAP) and holds a B.S. degree in Industrial and Systems Engineering 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.
He has experience working on Lean Six Sigma Projects and many Quality/Regulatory Affairs initiatives in the US and around the world including Third Party Auditing through Notified Bodies, Supplier Audits, Risk Management, Process Validation and remediation activities.
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. He regularly publishes articles to assist corporations in their quest for exceptional quality and regulatory compliance.