• EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes

    Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.

  • 8 Key Changes To Understand In The New European MDR And IVDR

    The new European MDR and IVDR regulations feature several significant changes and, while many medical device manufacturers already have started implementation efforts, this article aims to provide a quick summary of the key changes, aiding organizations in their transition plans.

  • A Simplified, Five-Step Approach To Applying FDA’s Human Factors Guidance

    FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices. 

  • Learn From Past Mistakes: Preparing For MDSAP And International Commercialization

    In today’s complex and constantly changing medical device world, it is more important than ever to fully understand regulations — particularly those regarding communication with Notified Bodies — to be able to comply with quality and regulatory requirements in Europe.

  • Understanding The Impact Of New European MDR And IVDR On Quality And Regulatory System Resources

    As a result of the European Union's new Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) adopted earlier this month, many adjustments will be required in the roles and responsibilities of medical device companies, manufacturers, importers, distributors, and authorized representatives.

  • Understanding The Changes To Clinical Evaluation Guideline: MEDDEV 2.7.1 Rev 4

    The MEDDEV guidance 2.71, revised by the European Commission this year, instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up.  

  • How To Develop A Quality Policy Built On Risk Management

    By incorporating risk management in the quality policy, the organization basically is adopting a preventive action approach to most activities performed under its quality system, a practice in alignment with the latest ISO 13485:2016 expectations. Risk management can be used after policy implementation for continuous improvement, as well.

  • Medical Device Single Audit Program (MDSAP) -- What Manufacturers Need To Know

    The Medical Device Single Audit Program (MDSAP) pilot is nearing its end and the 2017 MDSAP implementation is looming. While still viewed with a certain degree of suspicion, the program likely will become the new model to follow for most medical device manufacturers selling internationally. Read on to learn how your company can thrive in the new regulatory landscape this program will create. 

  • Summarizing The ISO 13485 Final Draft Changes

    The International Organization for Standardization (ISO) is revising ISO 13485, the international quality standard for medical devices. The final version is set for release early in 2016, and here we summarize the final draft's proposed changes to help you prepare for its publication and enforcement.

More Articles by Marcelo Trevino
Marcelo Trevino

Marcelo Trevino

Marcelo Trevino is the President, Global Regulatory Affairs and Quality Systems, at TregMedical Compliance Services, a life sciences consulting firm focused exclusively on regulatory, quality, and compliance solutions for medical device companies.

Marcelo has 23+ 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.