DFM, mold Flow analysis, and mold design
25-person engineering team, including 6 senior engineers with over 20 years of expertise.
Rapid toolings and production toolings
In-house tool manufacturing (We never outsource)
✅ Medical-Grade Plastics (PP, PE, PS, PVC): Commonly used for disposable medical consumables, connectors, containers, and single-use parts.
✅ Engineering Plastics (ABS, PC, PC+ABS, POM, PA, PBT): Suitable for medical device housings, structural parts, and functional components.
✅ Transparent Plastics (PC, PMMA, PETG): Used for clear housings, diagnostic parts, and fluid observation components.
✅ High-Performance Plastics (PEEK, PPSU, PSU, PEI): Ideal for parts requiring high heat resistance, chemical resistance, or repeated sterilization.
✅ Soft & Flexible Materials (TPE, TPU, Silicone): Suitable for seals, grips, tubing-related parts, and overmolded medical components.
✅ Modified Materials (Glass-filled, Flame-retardant, Reinforced Plastics): Used when higher strength, stiffness, or special performance is required.
We offer medical injection molding services including precision injection molding, insert molding, overmolding, two-shot molding, and custom mold making.
We support medical device housings, diagnostic equipment parts, disposable plastic components, transparent parts, soft-touch parts, and parts with metal inserts.
To request a quote for medical injection molding parts, please share your 2D drawings or 3D files, plastic material, expected order quantity, surface finish, tolerance requirements, and any special assembly or packaging needs.
After reviewing your files, Alpine Mold will provide a mold quotation, unit price, and estimated lead time.
If you do not have a 3D drawing, you can first share the product size, weight, material if known, and clear photos from different angles, especially detailed photos of key structures.
Based on this information, Alpine Mold can provide a preliminary estimate for the mold and parts. If the estimated cost is acceptable, you can then send us the physical sample for further evaluation.
After receiving the sample, our team can check the product structure more accurately, measure key dimensions, create 3D data if required, and provide a more accurate quotation for mold manufacturing and injection molding production.
Once we receive your 3D files and complete project information, Alpine Mold usually prepares the quotation within 2 working days.
For urgent projects, please mention your required timeline when contacting us. Our team will review your request as a priority and do our best to provide the quotation as quickly as possible.
4–7 weeks: Standard medical injection mold usually takes about 4 to 7 weeks, depending on part complexity, mold structure, steel selection, cavity number, tolerance requirements, and surface finish.
7–10 weeks: For more complex medical parts with sliders, lifters, thin walls, tight tolerances, transparent surfaces, or special mold structures, the tooling lead time may take around 7 to 10 weeks.
The lifespan of a medical injection mold depends on the mold steel, plastic material, part structure, production volume, and maintenance.
Sample mold: Usually used for prototype testing or low-volume production, around 5,000–50,000 shots.
Production mold: Designed for stable mass production, usually around 100,000–1,000,000+ shots.
Alpine Mold can recommend the suitable mold life based on your project quantity and production plan.
Our standard payment terms are as follows:
For mold projects:
40% deposit by T/T before mold manufacturing starts
30% payment before sending the first trial samples
30% balance after the final samples are approved
For mass production:
50% deposit before production starts
50% balance before shipment
| Material | Main Features | Common Applications |
| PP | Lightweight, good chemical resistance, cost-effective, suitable for disposable parts | Syringes, caps, containers, disposable medical components |
| PC | High transparency, strong impact resistance, good dimensional stability | Medical device housings, transparent covers, diagnostic equipment parts |
| ABS | Good toughness, easy processing, good surface appearance | Medical equipment housings, covers, handles, non-implantable plastic parts |
| POM | High stiffness, low friction, good wear resistance | Gears, clips, connectors, precision functional components |
| PA / Nylon | High strength, good wear resistance, good mechanical performance | Structural parts, connectors, handles, functional medical components |
| PEI | High heat resistance, good strength, suitable for repeated sterilization | Surgical instrument parts, sterilizable medical components |
| PEEK | Excellent heat resistance, chemical resistance, and mechanical strength | High-performance medical components, surgical instruments, specialty medical parts |
| TPU / TPE | Soft touch, flexible, good elasticity | Seals, soft grips, tubing-related parts, overmolded medical components |
| PMMA | High transparency, good optical clarity | Transparent covers, lenses, light guides, diagnostic device parts |
| PPSU | High heat resistance, strong toughness, suitable for repeated sterilization | Sterilizable medical parts, dental and surgical instrument components |
Medical injection molding projects usually require higher standards for safety, consistency, material control, and production traceability. For medical plastic parts, regulatory compliance is not only related to the final product, but also to design review, material selection, mold development, injection molding process control, inspection, and documentation.
ISO Standards
ISO 13485 is an international quality management system standard for medical devices. It focuses on quality control, risk management, production consistency, and traceability throughout the medical device manufacturing process.
ISO 10993 is commonly used to evaluate the biocompatibility of materials or products that may come into contact with the human body. For medical plastic parts, material selection and material documentation are important when biocompatibility requirements are involved.
ISO 14644 defines cleanroom classification requirements. Some medical device components may require production or packaging in controlled environments depending on the product application, cleanliness requirements, and customer specifications.
FDA Requirements
For medical device products entering the U.S. market, FDA-related requirements may need to be considered, such as quality system control, process validation, material traceability, inspection records, and manufacturing documentation.