Articles by Marcelo Trevino

31. 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.

32. 7 Steps To Survive Your Next Device Compliance Audit 4/11/2014

    While each type of audit carries its own unique set of specific guidelines and requirements, there are overarching audit management best practices you can follow to make your next experience more effective and less stressful. Follow these seven tips to ace your next audit, whether it’s with a regulator, a notified body, or any organization conducting a compliance assessment or investigation. By Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic