Articles by Marcelo Trevino

  1. 8 Key Changes To Understand In The New European MDR And IVDR 9/16/2018

    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.

  2. A Simplified, Five-Step Approach To Applying FDA's Human Factors Guidance 4/23/2018

    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. 

  3. Learn From Past Mistakes: Preparing For MDSAP And International Commercialization 9/11/2017

    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.

  4. Understanding The Impact Of New European MDR And IVDR On Quality And Regulatory System Resources 5/22/2017

    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.

  5. Understanding The Changes To Clinical Evaluation Guideline: MEDDEV 2.7.1 Rev 4 11/22/2016

    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.  

  6. How To Develop A Quality Policy Built On Risk Management 8/1/2016

    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.

  7. Medical Device Single Audit Program (MDSAP) -- What Manufacturers Need To Know 3/1/2016

    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. 

  8. Summarizing The ISO 13485 Final Draft Changes 11/5/2015

    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.

  9. How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 2 8/24/2015

    In Part 1 of this series, we discussed developing a risk management strategy for supplier evaluation, along with a qualification plan to demonstrate compliance to auditors/regulators. In this article, I will share best practices for implementing a successful risk-based supplier management system, as well as explain the requirements that should be clearly defined in a supplier quality agreement.

  10. How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 1 7/23/2015

    A number of well-publicized quality issues have prompted international regulators and standards organizations to require risk mitigation as part of a manufacturer’s quality management system. Additionally, outsourcing has become ubiquitous across the medical device supply chain. As a result, medical device companies now are re-evaluating their supplier management strategies, drilling into the underlying factors behind quality issues. In this article, I will explain how medical device manufacturers can address these issues by incorporating risk assessment into their supplier quality management plan.