 Introduction & Forever Chemicals
This white paper explores the history of Per- and polyfluoroalkyl substances (PFAS), how they are used in medical technology, why regulatory bodies have pushed for their removal, and strategies for medtech companies to successfully manage this transition.
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 Scaling from early-stage commercial operations to global medical device manufacturing demands precise execution. Our client, a Class III OEM, faced an urgent need to expand production capacity across multiple international facilities while meeting the strict regulatory requirements of the medical device industry. Square-1 Engineering partnered with the client to drive this transformation, with a focus on validation excellence, operational scalability, and long-term compliance.
 If you’re considering implementing or upgrading an Electronic Quality Management System (eQMS), this guide covers essential steps and considerations, specifically tailored to the unique needs of medical device companies. Leveraging SQR-1's extensive experience in helping clients scale eQMS tools, and incorporating insights from our interview with industry leader Robert Lahaderne, we'll provide valuable information to help you make an informed decision on selecting the best eQMS tool for your medical device company. A quick slideshow synopsis is available at the end of this post, as well (a little TL;DR)
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About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Archives
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