Medical & Aesthetic Device Injection Molding
ISO 13485-certified plastic injection molding for medical and aesthetic devices — from mold design and validated tooling to molding, finishing, and assembly under one roof in Tainan, Taiwan.
- Quality systems
- ISO 13485, ISO 9001, IATF 16949
- Service model
- OEM + ODM, one-stop (design → tooling → molding → assembly)
- Injection press range
- 80–850 tonnes
- Specialty capability
- Two-shot / 2K (double-shot) molding
- Tooling
- In-house mold design & manufacturing; single & multi-cavity
- Materials
- Medical-grade / biocompatible resins, optimal grade confirmed per application; broad resin range
- Cleanroom molding
- Controlled-environment / cleanroom where a program requires it, ISO class confirmed against your specification
- Experience & location
- Founded 1989 (40+ yrs); Anding District, Tainan, Taiwan
Medical & Aesthetic Device Molding, Built to ISO 13485
Medical and aesthetic devices place molded plastics under the strictest scrutiny of any sector — biocompatibility, dimensional repeatability, and a documented chain of evidence are non-negotiable. LongTeam runs medical and aesthetic device programs under an ISO 13485 quality management system, the international standard purpose-built for medical device manufacturing. Whether you are sourcing device housings, fluid-path components, handheld aesthetic instrument bodies, or single-use disposables, every part is produced against controlled processes and traceable records that your regulatory and supplier-quality teams can audit.
- ISO 13485 (medical devices), ISO 9001, and IATF 16949 quality systems
- Diagnostic and device housings, enclosures, and structural components
- Handheld aesthetic and beauty-device bodies and trim
- Single-use and disposable components
One-Stop OEM/ODM: From DFM to Validated Tooling to Finished Device
LongTeam is a one-stop OEM and ODM partner — we take a medical program from design-for-manufacturing review through in-house mold design and tooling, into injection molding, and on to post-processing and assembly. Keeping design, toolmaking, and molding under one roof shortens iteration loops, removes the finger-pointing between separate tool shops and molders, and gives you a single accountable supplier for the full device build. For programs requiring two materials in one part — soft-touch grips on an instrument body, sealed multi-material housings, or integrated gaskets — our two-shot (2K) molding eliminates a secondary assembly step and its associated contamination and inspection risk.
- In-house mold design and tooling — DFM through validated steel
- Single-cavity and multi-cavity tooling
- Two-shot (2K) molding for bonded multi-material parts
- Post-processing: polishing, printing, coating, welding, and assembly
Why Sourcing Matters: Validation, Traceability, and Supply Continuity
For device buyers, the cost of a molding defect is measured in field actions and regulatory exposure, not scrap. An ISO 13485 supplier generates the controlled documentation — process records, inspection data, and material traceability — that underpins your design history file and regulatory submissions, compressing your own qualification timeline. With 40+ years of molding experience and presses spanning 80 to 850 tonnes, LongTeam supports both precision small-cavity components and larger device enclosures, and exports to regulated markets across the US, Japan, Europe, India, and Southeast Asia.
- Material traceability and controlled process records
- Documentation that supports your DHF and regulatory submissions
- Experience exporting to US, EU, Japan, and other regulated markets
Materials & Cleanliness for Medical Applications
Medical and aesthetic devices commonly call for medical-grade and biocompatible resins — and LongTeam molds across a broad range of engineering and commodity material families, with grade selection driven by your device requirements and regulatory pathway. Where an application requires controlled-environment molding, cleanroom production, or specific material certifications, we will confirm scope against your specification before quoting so there are no surprises at validation.
- Medical-grade and biocompatible resin processing, with the optimal grade confirmed per application
- Engineering and commodity resins across many material families
- Cleanroom / controlled-environment molding where a program requires it, with the ISO class confirmed against your specification
- Material certifications and documentation per program requirement
Frequently asked questions
Related capabilities & industries
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