Navigate medical device regulations with confidence.
Strategic regulatory and quality consulting for medical device manufacturers to mitigate risk, strengthen global compliance, and reach markets faster.
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Accelerated Global Approvals
Fast-track your product to international markets with proven regulatory success. We've achieved 510(k) clearance in just 45 days, and CE Mark certification in under 50. Our team has expertise across Asia, Latin America, Canada, and Europe.
Robust Quality Systems
Ensure your operations meet the highest standards. Our team will help implement and maintain efficient quality systems compliant with ISO 9001, EN 46001, ISO 13485, ISO 14971, CMDCAS, MDR, and MDD requirements.
Internal & Supplier Audits
Maintain compliance and operational excellence with comprehensive audit services. We conduct federal, state, and ISO audits, oversee supplier inspections, and ensure adherence to HIPAA and other privacy regulations.
Product Lifecycle Support
Maximize the success of your medical devices from launch to market maturity. We offer strategic guidance to support Fortune 500 M&A activity, and leverage our global partnerships to optimize your product lifecycle.
About
SQS turns regulations into a competitive advantage for your business.
Founded in 2003 by Krishna Sudhakaran, our team brings decades of experience in medical device development and regulatory strategy. As a medical device startup founder herself, Krishna has led cross-functional teams across manufacturing, sales/marketing, and finance. This breadth of experience gives SQS a unique perspective on the regulatory landscape and its direct implications on business operations. Our deep understanding of compliance, quality systems, and global market requirements allows us to guide medical device manufacturers with strategic, practical solutions that accelerate approvals, mitigate risk, and strengthen operational excellence.
Email us at contact@sqscorp.com to learn more about how we can help you.