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Explore Our Success Stories
From early-stage design to FDA approvals and scalable manufacturing, our case studies showcase how we support clients in all phases of their medical device journey. Explore how we’ve helped companies like yours achieve faster timelines, reduced costs, and guaranteed regulatory compliance.
Validation: Class 7 Cleanroom ExpansionAs our client expanded into international ophthalmic production and supply, they faced a long-overdue, three-site overhaul of their manufacturing systems. Square-1 led the charge, completing over 175 equipment IQ/OQ/PQs and driving dozens of process and compliance upgrades. We crushed validation timelines, finishing at 230% of the original goal.
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QMS | Post Acquisition RemediationFollowing a major acquisition, our client faced urgent regulatory and quality challenges across U.S. and European operations. With only six weeks before an audit, they needed to quickly align two Quality Management Systems under EU MDR and MDSAP standards.
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Product Design & FeasibilitySquare-1 designs, develops and demonstrates successful prototype aiding client in goal of capturing market share by offering a universal delivery device at a lower cost
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Manufacturing COGS ReductionLearn how the Square-1 team helped our customer reduce the cost of manufacturing its console components, beating their cost savings expectations by 199%!
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Manufacturing Process ImprovementsSquare-1 leads start up medical device company through prototype catheter process revamp, avoiding near closure, by successfully transitioning prototype into scalable commercialized product
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M&A IntegrationAfter a 2024 acquisition, the seller struggled to maintain operations while integrating into its new parent company. Square-1 stepped in with a team of experts to stabilize systems, resolve audit findings, and streamline processes to ensure a smooth transition and uninterrupted business continuity.
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More Resources
Selecting the Right eQMS ToolAre you ready to adopt an electronic Quality Management System (eQMS)? Here are key factors to consider.
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Secrets to MedTech Product DesignStuart Karten walks us through the User Experience Pyramid, and how great MedTech product design impacts lives.
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Supplier SelectionWe break down how to identify potential suppliers and assess whether they’re the right fit for your needs.
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