We run the records a regulated build depends on — and keep them organized against the part, so the package is complete and audit-ready when you need it.
We perform and document First Article Inspection against your drawing before a production run — every dimension and specification verified and recorded — and hold the report on file against the part.
For builds that require a validated process, we run Installation, Operational, and Performance Qualification (IQ/OQ/PQ) on the molding process — agreeing the protocol up front, executing it, and compiling the validation package so the process is demonstrably under control.
Validation is executed on qualified equipment and compiled into the package you keep.
The Device Master Record is yours to own — we hand off the component-level records that feed it: drawings and specs, material certs, validation reports, and inspection records, organized against each part and kept current as revisions change.
Talk through your documentationThe supporting documentation a regulated component carries — produced and filed against the part.
Certificates of Conformance and Analysis (CoC / CoA) collected and matched to lot.
In-process and CMM inspection reports produced and held on file.
Material, run, and documentation traceable back to lot for every shipment.
Inspection and validation are performed and organized against the part; specific certification scope is confirmed per program.
Parts are produced under an ISO 13485 quality management system, with the documentation a Class I or Class II program is audited against. Where your device requires it, sterilization validation and biocompatibility testing run through qualified partners, and those records come back to you with the rest — one package, organized against the part.
The controls and records a regulated supplier is expected to hold — without the opacity that usually comes with them.
Tell us what your build has to document, and we’ll show you how the package comes together.