Simplify complex regulatory submissions
Cutting-edge software solutions for medical device and biopharma professionals
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Collaborative Partnership
Partner to develop software solutions tailored to meet your unique business needs
Streamlined Workflows
Standardize templates and reduce manual effort with AI -augmented authoring
Secure and Scalable
Adapt and grow with confidence as your organization evolves
Our Products
RegWriter™ AI-augmented authoring platform that improves efficiency, reduces costs, and simplifies your regulatory submission workflow
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SmartComplaintsTM automatically categorizes post-market complaints according to MDCG-recommended IMDRF Annex terminology
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