Articles by Marcelo Trevino
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.