Medical Device Housing Injection Mold Service PC Medical Grade Clean Room Molding

Medical device housings must satisfy strict cleanliness, dimensional, and traceability requirements. This injection mold service delivers medical grade PC and PC/ABS enclosures molded under controlled conditions for diagnostic, monitoring, and laboratory equipment.

We support validation documentation, tighter tolerances, and clean room production so that your device meets regulatory expectations from the first article onward.

• Medical grade materials: PC, PC/ABS, and PSU grades with material certification
• Clean room molding: controlled environment to limit particulate and contamination
• Tight tolerance: dimensional control to +/- 0.05 mm for mating assemblies
• Traceability: batch logs, material certificates, and inspection records
• Validation support: first article and capability data for your quality file
• Cosmetic polish: SPI A2 finish with clean gate vestige on visible parts

Medical programs are won on documentation and consistency, not only on price. We align tooling, process, and quality records with your regulatory flow.

• Design for assembly review to protect gasket sealing and snap fit integrity
• Clean room molding and clean handling to meet particulate targets
• First article inspection, capability studies, and inspection reports for validation
• Material substitution review to keep biocompatibility and cost in balance

• Diagnostic device housings and covers
• Patient monitoring enclosures
• Laboratory and analyzer instrument housings
• Handheld medical and dental device shells
• Drug delivery device covers and caps

With more than 18 years of focused experience in plastic injection molding, our factory runs an integrated tooling room, a clean injection workshop, and a controlled assembly line under one roof. We are ISO 9001:2015 certified and export precision molds and molded components to over 40 countries across Europe, North America, and Southeast Asia, supporting OEM and ODM programs from concept to serial delivery.

• 18 years of OEM and ODM experience in plastic injection molding with an integrated tooling room and clean injection workshop
• Injection machines from 60T to 1600T, all fitted with controlled robotic handling systems
• Advanced equipment and skilled engineers covering CNC machining, EDM, wire cutting, mold flow analysis, and DFM reporting
• In-house prototyping, tooling, injection, painting, printing, and assembly services delivered under one roof
• Experienced quality team performing dimensional inspection with CMM and 3D scanning before every shipment

Reference lead times are shown above. Share your drawing and volume and we will confirm an exact tooling and validation schedule in the DFM quotation.

• A European medical OEM qualified a PC device cover through our clean room molding line with full first article data in a single validation cycle.
• A US diagnostics maker reduced part rejection by tightening tolerance to +/- 0.05 mm on a mating housing pair.
• An Asian lab equipment brand runs a family mold for three instrument covers to cut tooling spend.

Molds ship in a treated wooden case with anti-rust film and a mold report. Molded parts are sealed in clean room bags, packed in cartons, and accompanied by material certificates and dimensional records to support your quality system.

Q1. Can you make a prototype for us?

Yes. We produce prototypes by CNC machining and hand polishing so that fit, finish, and function can be validated before tooling is cut.

Q2. How can I place an order?

Send your 2D and 3D drawings (a .step file is preferred) together with annual volume, material, and surface requirements. Our engineers reply with a DFM report and quotation within one working day.

Q3. How can I get a sample to check your quality?

After price confirmation you can request samples. For a new mold we provide T1 samples for evaluation; the buyer covers the express freight.

Q4. Can you do the design for us?

Yes. Our design team has rich experience in plastic products and molds. Share your idea or a reference part and we will refine it into a manufacturable design.

Q5. How long can I expect to get the sample and mass production?

For an existing mold, samples take 3-7 days and mass production 1-2 weeks. For a new mold, allow 25-35 days for mold building plus 1-4 weeks for mass production.

Q6. What are your terms of delivery?

We accept EXW, FOB, CFR, CIF, DDU, and DDP. Choose the option that best fits your cost and logistics plan.