TL;DR: We mold plastic components for medical products under an ISO 13485–driven quality system, from DFM and material selection through IQ/OQ/PQ validation, traceability, and packaging. We support new tools and mold transfers, coordinate sterilization readiness (EtO, gamma, e-beam, steam) with validated partners, and provide the documentation you need for audits and launches.
What kinds of medical products do you support?
Diagnostics and point-of-care disposables, drug-delivery components, housings and enclosures, caps/closures, fluid-path parts, and miniature/high-precision components. Share your CTQs and regulatory context and we’ll map the right process window and documentation.
Are you ISO 13485 certified?
Yes—we operate to ISO 13485 for medical work. We maintain controlled procedures, training, calibration, nonconformance/CAPA systems, and device history documentation. Ask us for our current certificate and quality manual table of contents.
Do you accept mold transfers or only build new tools?
Both. For transfers, we audit tool condition, documentation, prior settings, and spares, then run a qualification plan to establish a validated process window before production.
How do you approach DFM for medical parts?
Early DFM covers gate location, wall uniformity, draft, knit-line management, venting, and tolerancing. We can provide mold-flow guidance when needed and align GD&T with realistic capability targets before tool steel is cut.
Do you provide cleanroom molding?
We provide controlled clean handling and packaging in-house and can run in partner cleanrooms if your program requires a specific ISO class. We’ll define gowning, environmental monitoring, and packaging protocols with you in the control plan.
Which sterilization methods will my part tolerate?
We routinely plan for EtO, gamma, or e-beam (and steam where appropriate). We help match resin + additives + colorants to the sterilization method and can coordinate testing with your sterilization provider.
How are materials selected and documented?
We source medical-grade resins where available, manage lot traceability, and maintain CoA/CoC records. If your file requires ISO 10993/USP Class VI support or additive disclosure, we work with suppliers to provide the needed statements.
What validation do you run—do you follow IQ/OQ/PQ?
Yes. We execute or support IQ (installation), OQ (process characterization), and PQ (performance/PPQ) per agreed protocols, with pFMEA, control plan, MSA (gage R&R), and capability (Cpk/Ppk) where specified.
What documentation will I receive for each lot?
At minimum: DHR/lot traveler, material and colorant CoA/CoC, in-process and final inspection records, and label/pack verification. We align with customer templates and secure digital copies for audits.
Can you help with UDI and labeling?
Yes—provide your UDI and label specs, and we’ll implement lot/serial tracking and label verification in the pack plan.
Do you offer secondary operations?
Yes—ultrasonic welding, pad printing, insert/overmolding, assembly, kitting, and protective packaging suitable for your sterilization pathway and cleanliness needs.
How tight are the tolerances you can hold?
It depends on geometry, material, and tool design. We’ll propose capability-backed tolerances during DFM and confirm with OQ studies; for micro-features we’ll review gate style, steel condition, and measurement strategy up front.
What do you need to quote a medical part?
3D CAD + 2D drawing with CTQs, estimated annual volume, target resin/color, sterilization method, cleanliness/packaging requirements, and any regulatory deliverables (e.g., ISO 10993 expectations, validation scope).
How do you protect IP and tooling?
We work under NDA, restrict access to controlled documents, and maintain tooling logs for maintenance and storage. You retain tool ownership per the contract.
Have a medical part to launch or transfer? Email sales@advantechplastics.com
with CAD, CTQs, volume, and sterilization plan—or start an RFQ and ask for a DFM + validation roadmap.