Articles by Marcelo Trevino

  1. 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. 

  2. 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.

  3. 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.

  4. 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.

  5. ISO 9001:2015 — What Medical Device Manufacturers Need To Know 4/9/2015

    ISO 9001:2015, which will likely be published in the fall of this will give medical device companies a preview of some forthcoming revisions to ISO 13485 and a head start on implementing the necessary changes to ensure compliance. This article will review some of the critical changes in the current draft international standard (DIS) that we can reasonably expect to see in ISO 9001:2015, what these changes will mean to medical device manufacturers, and what they can do to start preparing.

  6. What To Expect From The Upcoming ISO 13485 Revisions, Part 3 12/2/2014

    The International Organization for Standardization (ISO) is currently in the process of revising ISO 13485, the international quality standard for medical devices. When the final version is released — potentially in 2015 — it will be the first revision to the standard in over a decade. In this three-part article series, we are looking at the proposed changes to ISO 13485, to help you prepare for its eventual publication and enforcement.

  7. What To Expect From The Upcoming ISO 13485 Revisions, Part 2 10/28/2014

    The International Organization for Standardization (ISO) is currently in the process of revising ISO 13485, the international quality standard for medical devices. When the final version is released — potentially in 2015 — it will be the first revision to the standard in over a decade. In this three-part article series, we are looking at the proposed changes to ISO 13485, to help you prepare for its eventual publication and enforcement.

  8. What To Expect From The Upcoming ISO 13485 Revisions, Part 1 9/26/2014

    Earlier this month, 50 delegates from ISO Technical Committee 210 Working Group 1 met in Stockholm to review comments submitted by industry on the draft international standard of ISO 13485, the international quality standard for medical devices. In this three-part article series, we will look at the anticipated changes to ISO 13485, to help you prepare for its eventual publication and enforcement. This installment will explore the primary motivations behind the revisions and discuss what’s new in sections 4 through 6.

  9. Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2 8/19/2014

    In Part 1 of this article, we looked at five mistakes medical device companies make during the quality management review process. In this installment, we turn our attention to measurement, analysis, and improvement activities — where several problems can occur and what you can do to prevent them. By Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

  10. Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 1 8/6/2014

    Establishing and maintaining an airtight quality system is a prerequisite for survival in the medical device and diagnostics industry. Problems can arise in many areas of a quality system, but one area where manufacturers struggle is in management reviews. This article identifies some of the common snares manufacturers fall prey to when conducting these reviews, and shares strategies to help you avoid those mistakes in your organization.