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 Expansion
Our client was transitioning into an international producer and supplier of ophthalmic products and was overdue for a company wide, three site, overhaul of its manufacturing systems. The Square-1 team lead it client through 175+ equipment IQOQPQs and dozens of process and compliance upgrades. Equipment validation timing achieved 230% of goal.
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CAD Services
Square-1 offloads hundreds of subassembly drawings from instrumentation developer to aide their internal teams in focusing on mission critical project work while successfully meeting deadlines with a 99% 1st iteration accuracy rating
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System Builds
Square-1 turns around clients failing project, performing hardware build and software development and verification on hydrophilic coating system; successfully met aggressive deadline 2 weeks in advance allowing customer to ship system internationally on time
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QMS Remediation (Class III)
Square-1 successfully addresses two (2) large scale device manufacturers regulatory warning letter via companywide quality management system overhaul and supplier accountability matrix
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Manufacturing COGS Reduction
Learn 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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Product Design & Feasibility
Square-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 Process Improvements
Square-1 leads start up medical device company through prototype catheter process revamp, avoiding near closure, by successfully transitioning prototype into scaleable commercialized product
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More Resources
Supplier Selection for Early & Mid-Stage Medical Device Companies
We break down how to identify potential suppliers and assess whether they’re the right fit for your needs. |
White Papers & Articles
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