Quality Means Business

Founded 2023

Prepare FDA submission documents and match predicate devices for medical devices

Pricing model

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You can use QMB to prepare medical device submissions for FDA clearance and international compliance. It automates product code classification, identifies predicate devices, and generates submission documentation aligned with FDA, EU MDR, and ISO 13485 standards. The system highlights regulatory risks using compliance benchmarks to prevent review delays and rejection notices. Medical technology teams and regulatory specialists can track clearance milestones, manage design planning documents, and collaborate with regulatory experts in a centralized workspace to accelerate new product development from concept to market approval.

What Quality Means Business does

Generate FDA submission draft documentsSelect appropriate medical device product codesSearch and benchmark predicate devicesFlag submission risks and missing dataReview compliance against ISO 13485 standardsPrepare verification and validation documentationCoordinate regulatory reviews with external compliance specialistsAutomates medical device product code selection and classificationIdentifies and matches predicate devices for FDA filingsGenerates FDA-ready submission and design planning documentsFlags regulatory risks against real-world FDA benchmarksAligns documentation across FDA, EU MDR, and ISO 13485 standardsProvides expert regulatory review and document validationSimulates FDA submission reviews to detect potential file rejections

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