Medical Injection Molding
ISO 13485 medical injection molding for regulated plastic components—built around CTQ control, traceability, and controlled handling.
- ISO 13485 certified (traceability + change control)
- Cleanroom option: Class 100,000 (ISO Class 8)
- Optional inspection: FAI / CMM dimensional reports
- Lot traceability & ECN change control
- CTQ control for fit, sealing, and cosmetic zones
- All uploads are secure and confidential
Medical Injection Molding Services
We build tooling and run production molding for regulated medical device parts. Programs are managed with CTQ control, lot traceability, and documented change control.
- 20+ years in the medical industry
- 100+ medical projects supported
- Up to 5 million units of annual production capacity
Medical Injection Molding Capabilities
| Capability | Details |
|---|---|
|
Quality system |
ISO 13485 certified (traceability + change control) |
|
Machine tonnage range |
50–1300T |
|
Max part envelope |
Up to 600 mm (dimension dependent) |
|
Typical tolerance |
±0.02 mm (tighter on defined CTQs, as reviewed) |
|
Cleanroom / controlled handling |
Class 100,000 (ISO Class 8); handling and packaging per your specification |
|
Materials (common medical resins) |
PC · PP · PE · ABS · POM · PA (Nylon) · TPE/TPU · PEEK (grade per spec) |
|
Processes |
Tooling + production molding · insert molding · overmolding · thin-wall builds (as reviewed) |
|
CTQ focus |
Datums / true position · sealing lands & mating faces · cosmetic zone control |
|
Inspection & documentation (optional) |
FAI · CMM dimensional reports · inspection records · lot traceability records · revision/ECN change control · COA/COC (as required) |
|
Secondary ops & packaging (optional) |
Deflashing/trimming · insert installation · ultrasonic welding / heat staking · pad printing / laser marking · spec-based packaging & labeling |
Medical Parts We Mold
Common medical device part types with CTQ-focused molding controls.
Housings & Covers
Cosmetic zones and assembly fit are kept consistent to avoid visible defects and rework at assembly.
Sealing Interfaces
Sealing grooves and mating faces are managed as CTQs to reduce leak risk and compression variation.
Connector & Sensor Features
Alignment and true-position features are held to protect engagement, clearance, and functional location.
Snap-Fit & Assembly Features
Snap and retention geometry are stabilized to keep insertion force and lock performance repeatable.
Overmolded / Insert-Molded Parts
Insert capture and bond interfaces are controlled to prevent movement, pull-out, or edge lifting.
Disposable Components
Repeat builds and spec-based packaging are aligned to support reliable supply for single-use programs.
Why Choose Kemal for Medical Injection Molding
Predictable Lead Times
Tooling and molding are kept in-house, so your schedule does not rely on outsourced capacity. We follow a clear process from DFM to T0 and sample approval, with regular progress updates during the build.
DFM Support
DFM is done before steel cutting to review shrinkage, warpage, cosmetic areas, and sealing features. We provide a free DFM review to flag design risks early and reduce repeated mold changes.
ISO 13485 Certified
ISO 13485 certification supports medical programs that require controlled processes, documented records, and traceable production. Certification details and audit information are available during supplier qualification.
Cleanroom Injection Molding
Cleanroom injection molding is supported when your parts require controlled handling and cleanliness. The level of cleanroom handling and packaging follows your product and regulatory requirements.
CTQ Control
CTQs are defined early for fit, sealing, and cosmetic surfaces. Key dimensions are measured and tracked to keep assembly performance and appearance consistent from samples to production.
Lot Traceability and Change Control
Material lots, build history, and revision changes are tracked to support audits and controlled updates. When a change is needed, the impact on CTQs, tooling, and timing is documented first.
Cleanroom Injection Molding
Cleanroom injection molding is supported for medical parts that require controlled handling and cleanliness.
- Class 100,000 (ISO 8) environment available when required
- Controlled handling to reduce contamination risk
- Spec-based packaging and labeling supported
- Documentation available for qualification and audit needs
Our Manufacturing Capabilities for Medical Device Parts
Injection Mold Making
We specialize in providing cost-effective mold manufacturing solutions for the medical industry. High-quality injection molds not only ensure the high precision and consistency of medical devices but also meet stringent hygiene and safety requirements.
Injection Molding Services
We provide high-quality injection molding services tailored for medical devices. Our expertise lies in producing complex plastic parts that adhere to the rigorous standards of the medical industry, ensuring superior quality and consistency.
Trusted by Leading Healthcare and Medical Companies
- Medical Device Companies
- Bionics development companies
- Hospitals
- Healthcare institutions
- Dental implant manufacturers
- Pharmaceutical companies
- Surgical equipment manufacturers
FAQ's
What tolerance can you typically hold for medical parts?
Typical tolerance: ±0.02 mm; tighter CTQ tolerances are evaluated case-by-case based on geometry, material, and inspection method (fixture vs CMM).
Do you support PPAP or regulated documentation?
Yes. For regulated medical programs, we can support regulated documentation as required, including:
FAI / dimensional inspection reports (CMM optional)
Lot traceability records
Revision / ECN change control records
COA / COC (as specified)
Do you offer cleanroom injection molding?
Yes. We offer cleanroom injection molding as needed, including a Class 100,000 (ISO Class 8) cleanroom option, with controlled handling and spec-based packaging.
Can you do insert molding or overmolding for medical components?
Yes—insert molding and overmolding are supported. We review insert retention, material compatibility/bond performance, and tool design (gating, venting, and shutoffs) early to reduce misloads, flash, and bond-line defects.
What inspection reports can you provide?
We can provide FAI (First Article Inspection) and dimensional inspection reports, with CMM measurement/reports available as an option based on your inspection plan and CTQ requirements.
Trusted by Industry Leader Companies
500+ global companies depend on Kemal for precision injection molding and custom mold design.
