Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
FDA’s 2026 PPI guidance encourages voluntary collection of patient preference information across the total product life cycle. Devices with direct patient interfaces, subjective outcomes, or high risks benefit most. PPI supports premarket submissions, labeling, and post-market evaluation. Guidance aligns with EU MDR/IVDR PMCF/PMPF principles, helping assess patient risk tolerance and benefit-risk trade-offs. Manufacturers should collect scientifically valid PPI to inform regulatory decision-making and enhance patient-centered device development.
From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments.
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