ISO 13485:2016 — Medical Device QMS
Our medical injection molding partner is certified to ISO 13485:2016, adopted in China as GB/T 42061-2022 — the international quality management standard specifically for medical device manufacturing and its regulatory requirements.
ISO 13485 governs design, production, and traceability controls for medical device components. For our OEM/ODM clients, it means documented process control, material traceability, and a quality system aligned with the regulatory expectations of markets such as the EU MDR and US FDA supply chains.
ISO 9001:2015 — General Quality Management
Our CNC machining is arranged with manufacturing partners operating under an ISO 9001:2015 quality management system, covering custom precision parts for industrial, automotive, and general engineering clients worldwide.
Relevant manufacturing and compliance documentation can be provided according to project requirements. For supplier confidentiality, certain manufacturing partner details may be provided in redacted form during the initial evaluation stage; full documentation can be reviewed when required for regulatory, compliance or formal order purposes.
Quality Control on Every Order
CMM Inspection
Dimensional verification on a TESA coordinate measuring machine. Every batch ships with a dimensional report.
Material Certificates
Mill test reports (MTR) and material certificates provided as standard for full traceability.
First Article Inspection
FAI reports on new parts confirm the first production article matches the approved drawing before full run.
Medical-Grade Materials
USP Class VI / ISO 10993 polymers available for medical components, with EO-compatible designs.