ARTICLES BY MARCELO TREVINO
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![Avoid pitfall-GettyImages-1394513236]( "Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters")
Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters8/19/2025This article focuses on practical strategies for medical device companies to strengthen their quality management systems and develop proactive programs that anticipate issues before they attract FDA action.
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The Warning Letter Wake-Up Call In 2025: What FDA Enforcement Is Really Telling Us8/12/2025
FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.
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Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight6/23/2025
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 25/13/2025
This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.
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AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 15/1/2025
This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices.
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Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K.3/26/2025
Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.
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Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors2/24/2025
Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.
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9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond12/17/2024
Current challenges in Europe's medical device market include the EU MDR transition and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change.
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Understanding The New MHRA Requirements For Medical Devices In Great Britain4/9/2024
The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.
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The FDA & EU IVDR Regulatory Frameworks For IVD SaMD1/4/2023
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.
Marcelo Trevino
Marcelo Trevino has more than 25 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, in vitro diagnostic devices, and medical device sterilization and disinfection products. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, MDSAP). He holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. Trevino is also a certified Medical Device Master Auditor and Master Auditor in Quality Management Systems by Exemplar Global. He has experience working on Lean Six Sigma Projects and many quality/regulatory affairs initiatives in the U.S. and around the world, including third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation. He can be reached at marcelotrevino@outlook.com or on LinkedIn.