ARTICLES BY MARCELO TREVINO
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![Puzzle Flag-GettyImages-946323472]( "9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond")
9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond12/17/2024Current 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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![Judge Gavel and Flag of United Kingdom GettyImages-535769117]( "Understanding The New MHRA Requirements For Medical Devices In Great Britain")
Understanding The New MHRA Requirements For Medical Devices In Great Britain4/9/2024The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.
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.