ISO 13485-Certified Medical Tooling&Cleanroom Injection Molding

From precision tooling to cleanroom production for medical and drug-delivery components.

✓ ISO 13485 and ISO 9001 quality management systems

✓ Class 10,000 and Class 100,000 cleanroom capability

✓ Precision molds, inserts and small-batch validation support

Category:

Description

From precision tooling to cleanroom production for medical and drug-delivery components.

✓ ISO 13485 and ISO 9001 quality management systems

✓ Class 10,000 and Class 100,000 cleanroom capability

✓ Precision molds, inserts and small-batch validation support

ISO 13485

Medical QMS

37 CNCs

Machining

0.00028 mm

Measurement

120+

Professionals

Cleanroom

10K / 100K

200 Sets

Annual molds

Complete Medical Manufacturing Solution

✓ DFM review before tooling release

✓ Precision mold and insert manufacturing

✓ Mold validation and cleanroom molding support

DFM Review

Precision Tooling

Mold Validation

Cleanroom Molding

Medical Applications

[ Blood Treatment ] [ Drug Delivery ] [ Diagnostic Devices ] [ Medical Connectors ] [ Disposable Medical ]

Precision That Supports Medical Requirements

✓ Micro-feature mold inserts and components for demanding medical applications

✓ 5-axis machining for complex angles, curved surfaces and multi-side features

✓ Precision grinding, coordinate grinding and EDM for critical fitting details

✓ ZEISS dimensional verification with highest stated measurement accuracy of 0.00028 mm

✓ Experience with PC, PP, PEEK, PMMA and other medical engineering plastics

Representative Medical Case

Project Item	Representative Result
Application	Medical filtration component
Mold configuration	8 cavities
Critical feature	24 micro-grooves per component
Drawing requirement	0.10 mm, tolerance 0 / -0.02 mm
Actual result	0.094–0.097 mm
Inspection / cycle	Mitutoyo QV / 7 weeks to sample approval