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Medical Device Make vs Buy Analyzer

AI enabled tool for Supply Chain Analysts to leverage Manufacturing and Regulatory Data

Bulk mode: upload Excel or CSV with columns: Manufacturer, Device, Volume
Batch Queue
Known Pricing Optional — populate any fields you already have
Device Characteristics Drives the Regulatory NRE estimate
The model pre-fills these from the device name when you run an analysis — you are the expert on your device, so confirm or correct them. They determine which 510(k) cost stages apply.
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Patient-contactingTriggers biocompatibility (ISO 10993)
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Provided sterileTriggers sterilization + shelf-life
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Electrically poweredTriggers electrical safety + EMC
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Contains softwareTriggers software V&V + cybersecurity
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ImplantableEscalates biocompatibility scope
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Small businessGross receipts ≤ $100M — reduced FDA fee

Enter device details above to begin

Or upload an Excel list for bulk analysis
Email RFQ to Supplier
PDF will download & your email client will open