Home > Project Execution > Case Studies
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.
|
|
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.
|
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
|
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%!
|
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
|
M&A IntegrationAfter a 2024 acquisition, the seller struggled to maintain operations while integrating into its new parent company. Square-1 stepped to ensure a smooth transition and uninterrupted business continuity.
|
EU MDRA Class III global medical device manufacturer needed to bring eight product lines into full compliance with EU MDR requirements.
|
Global Product ExpansionScaling three facilities while chasing global demand looks impossible until the right plan takes hold. This case study shows how a fast-growing Class III OEM boosted output, tightened quality, and crushed its validation goals with help from our team.
|
NPD Quality EngineerWith limited internal bandwidth and growing regulatory pressure, a Class II medical device manufacturer needed experienced support to stabilize documentation, maintain compliance, and keep development moving without delay.
|
More Resources
Selecting the Right eQMS ToolAre you ready to adopt an electronic Quality Management System (eQMS)? Here are key factors to consider.
|
Secrets to MedTech Product DesignStuart Karten walks us through the User Experience Pyramid, and how great MedTech product design impacts lives.
|
Supplier SelectionWe break down how to identify potential suppliers and assess whether they’re the right fit for your needs.
|
