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DICOM-Numpy — DICOM-Numpy 0.1.1 documentation
Description: Innolitics helps Medtech companies create and clear Software as a Medical Device (SaMD). We help with regulatory strategy, software and AI/ML development, writing design documentation, and regulatory submissions.
Contact Us Portfolio Services About Articles 10x Careers Medical Device Software & Regulatory Services We help Medtech companies create and clear Software as a Medical Device (SaMD). We can develop your regulatory strategy, build your software (including AI/ML and cybersecurity), draft your design documents, and submit your FDA 510(k) in as little as three months. Where are you on your Medical-Device Journey? Our medical-device services span from strategy, to market clearance, and beyond:
Strategy Build and Validate Innolitics’ Medtech OS FDA Clearance Expand Strategy: If you’re just starting out and need general guidance, we can help you determine if your product is a medical device and find a path to market. Our combined software and regulatory expertise lets us find strategies for AI/ML and SaMD devices that most regulatory firms couldn't. Build and Validate: If you're looking for an experienced team of engineers to develop your software, optimize your AI/ML models, handle cybersecurity,
Innolitics is an incredible partner and consistently surpasses our expectations. They have an extremely agile team, adapting to our needs across back-end and front-end tasks seamlessly. When we needed support around ISO 62304 compliance for FDA requirements, they jumped right in and provided us compliant documentation. They also assisted us as we developed a regulatory strategy around FDA Cybersecurity and HIPAA Compliance. The Innolitics team is efficient, fair, and highly ethical. They are an absolute ple
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DICOM-Numpy — DICOM-Numpy 0.1.1 documentation