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    Marcelo Trevino

    Global Regulatory Affairs & Quality - ISO 13485 - FDA - MDSAP - EU MDR/IVDR - Lead Auditor - 510(k)/PMA - Six Sigma -

    Marcelo Trevino is a seasoned professional with over 25 years of experience in global regulatory affairs, quality, and compliance in the medical device industry.12 He currently serves as the President of Global Regulatory Affairs and Quality Systems at TregMedical, a life sciences group focused on global medical device regulatory, quality, and compliance.14

    Trevino's expertise spans various medical devices, including surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, and medical imaging/surgical navigation.14 He has extensive knowledge of medical device management systems and regulations worldwide, including ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, and MDSAP.12

    His educational background includes:

    • B.S. in Industrial and Systems Engineering
    • MBA in Supply Chain Management from the W.P. Carey School of Business at Arizona State University12

    Trevino holds several certifications:

    • Certified Six Sigma Black Belt (ASQ)
    • Certified Biomedical Auditor (ASQ)
    • Medical Device Master Auditor (Exemplar Global)
    • Master Auditor in Quality Management Systems (Exemplar Global)12

    He has experience in Lean Six Sigma projects, third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation activities.12 Trevino regularly publishes articles to assist corporations in their quest for exceptional quality and regulatory compliance.1

    As of April 17, 2023, Trevino joined Advanced Sterilization Products as their new Vice President of Global Regulatory Affairs & Quality Assurance.3

    Highlights

    Mastering EU MDR IVDR Certification Compliance For Medical ...
    Analyzing The Changes To Risk Management Standard ISO 14971 ...
    A Simplified Five-Step Approach To Applying FDA's Human Factors ...

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    Marcelo Trevino
    Marcelo Trevino, photo 1
    Marcelo Trevino, photo 2
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    Location

    Greater Los Angeles Area