Simplify complex regulatory submissions

Cutting-edge software solutions for medical device and biopharma professionals

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Partner to develop software solutions tailored to meet your unique business needs

Standardize templates and reduce manual effort with AI -augmented authoring

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

SmartComplaints^TM automatically categorizes post-market complaints according to MDCG-recommended IMDRF Annex terminology