Quality & Validation / Documentation & records
The artifacts a component manufacturer ships with every lot — and where they fit your records.
Every Emersion component ships with the standard medical-component documentation set: a Certificate of Conformance (CoC) to the agreed specification, material certification / Certificate of Analysis (resins selected from medical grades with USP Class VI and ISO 10993 biocompatibility, and a Drug Master File reference where applicable), full lot traceability, and dimensional inspection reports on request. First Article Inspection and IQ/OQ/PQ validation records are available per program.
Need a particular format or an extra artifact — a specific CoA layout, a residuals statement, a packaging spec? We map your incoming-inspection checklist before the first shipment, so the paperwork clears on receipt instead of bouncing back.
For our off-the-shelf catalog components, Emersion holds the controlled specification and device master record for the component itself and supplies the CoC, material certs, and traceability that document each lot — you don’t inherit a DMR obligation for a standard part.
For custom molded parts that go into your finished device, those same artifacts feed your Device History Record; your device’s DMR and DHR remain yours. Either way, every lot is traceable from raw resin through molding, inspection, and shipment under an ISO 13485 / 21 CFR 820 quality system.
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