ARTICLES BY MARCELO TREVINO

  • Implementing EU MDR and IVDR: Lessons Learned, Part 2
    3/31/2021

    The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

MT

Marcelo Trevino

Marcelo Trevino is the global vice president, regulatory affairs and quality assurance at Agendia, a molecular diagnostics company focused on breast cancer genomic testing.

Previously, he was the President, Global Regulatory Affairs and Quality Systems, at TregMedical, a life sciences group focused on global medical device regulatory, quality, and compliance. Marcelo can be reached at marcelotrevino@outlook.com or on LinkedIn (https://www.linkedin.com/in/marcelo-trevino-0015921).

Marcelo has more than years’ experience in quality and regulatory affairs, serving in multiple senior leadership roles with different organizations while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation amongst others. 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). Mr. Trevino 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.

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.