The documentation and validation your build has to have.
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.
FAI — proof the first part meets every callout.
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.
- Dimensional and specification verification to the drawing
- Documented and signed off
- Filed against the part for re-qualification
IQ / OQ / PQ, provided.
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 records that feed your DMR.
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 documentation
Every record chased, checked, and kept in order.
The supporting documentation a regulated component carries — produced and filed against the part.
Material certs
Certificates of Conformance and Analysis (CoC / CoA) collected and matched to lot.
Inspection & metrology
In-process and CMM inspection reports produced and held on file.
Lot traceability
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.
The standards your records have to satisfy.
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.
- ISO 13485 — medical-device quality management system
- ISO 80369 — small-bore connector safety (luer, ENFit, NRFit)
- USP Class VI · ISO 10993 — material biocompatibility
- ISO 14971 — risk management alignment
- 21 CFR 820 — quality system regulation
Need the paperwork to hold up?
Tell us what your build has to document, and we’ll show you how the package comes together.