What we do
Regulatory Compliance Strategy
If you're a SaMD startup, navigating ISO 13485 compliance can be daunting. We're here to guide you in setting up and managing a Quality Management System (QMS) that fits your business. We help you integrate it smoothly into your operations, keeping risks low and ensuring product quality and compliance as you grow.
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Data Management, Strategy & Compliance
Your data is valuable, but staying compliant with regulations like GDPR and HIPAA can be tricky. We assist you in developing a smart data strategy that protects your business, keeps you compliant, and helps you unlock the full potential of your data—whether you're looking to grow or monetize it.
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We're a hands-on consulting firm that helps SaMD startups navigate software development, data management, and regulatory compliance. With real-world experience in setting up ISO-certified QMS, building software teams, and designing architectures, we know how to get your product market-ready.
We've been through the process ourselves, so we get the balance between technical demands and regulations like GDPR, HIPAA, and AI. Our goal is to help you grow, reduce risks, and launch your product—while keeping quality and compliance at the forefront.
