ISO 13485-Aligned Quality Management

At Sochen MedTech, quality is verified, not assumed. Our rigid Quality Management System (QMS) ensures every medical component manufactured within our cleanroom facility meets the exacting tolerances and compliance standards required by global medical innovators.

Core Manufacturing Standards

Full Medical-Grade Traceability

We enforce strict material control protocols. Every batch is fully traceable. We provide original Technical Data Sheets (TDS), Certificates of Analysis (COA), and batch tracking logs to ensure absolute raw material integrity.

Class 100,000 Cleanroom

Our medical injection molding operates within a strict ISO Class 8 (Class 100,000) environment, enforced by mandatory air showers and continuous airborne particle monitoring.

Rigorous Inspection Protocol

Quality is verified at IQC, IPQC, and OQC. We conduct First Article Inspections (FAI) and provide Full Dimensional Measurement Reports via CMM with your shipments.

Medical NDA & IP Protection

Your designs are secure. We execute mutual Non-Disclosure Agreements (NDA) prior to CAD evaluation, keeping your IP strictly confidential on isolated internal networks.

Facility & Equipment Capabilities

In-house Medical Grade Resin Compounding and Raw Material Silos

In-House Resin Compounding

Unlike standard molders, we produce our own medical-grade modified raw materials in-house. This vertical integration significantly reduces manufacturing costs and allows us to seamlessly process customer-specified resin grades.

ISO Class 8 Cleanroom Medical Injection Molding Worker

Controlled Cleanroom Operations

Our technicians operate 50T to 300T all-electric precision injection machinery entirely within our Class 100,000 cleanroom, ensuring contamination-free medical component production.

Medical Device Quality Control Metrology and CMM Lab

Advanced In-House QC Lab

Fitted with Coordinate Measuring Machines (CMM), 2.5D Vision Systems, and tensile testing equipment to rigorously verify that every part meets micro-molding tolerances.

Medical-Grade Materials Database

Resin Type Key Characteristics Medical Applications Compliance
Medical PC (Polycarbonate) High impact resistance, sterilizable, excellent clarity. Surgical instruments, IV connectors, blood oxygenators. ISO 10993, USP Class VI
PEEK Extreme chemical & heat resistance, highly biocompatible. Dental implants, surgical handles, orthopedic devices. ISO 10993
Medical PP (Polypropylene) Superb chemical resistance, excellent fatigue strength. Syringes, diagnostic test kits, lab consumables. FDA Compliant
LSR (Liquid Silicone Rubber) Biocompatible, highly flexible, extreme temp tolerance. Catheters, respiratory masks, medical seals. ISO 10993, USP Class VI

Technical Specifications & FAQ

What is your standard lead time for medical OEM projects?
Comprehensive DFM reports are provided within 24-48 hours. T1 tool sampling typically takes 15-25 days depending on mold complexity, followed directly by rapid mass production.
Can you achieve micro-molding tolerances for IVD consumables?
Yes. Our precision injection machinery enables us to achieve tight molded tolerances down to ±5–8 µm (Target Cpk ≥ 1.33) for microfluidic chips, optical components, and IVD cartridges.
Do you handle secondary operations and sterile packaging?
We provide end-to-end solutions. Beyond injection molding, our cleanroom operations include ultrasonic welding, precision assembly, and sterile blister packaging preparations.

Ready to Start Your Medical OEM Project?

Our engineering team is on standby. Send us your 3D CAD files today for a comprehensive DFM evaluation and preliminary quote within 24 hours.

Chat with our 24/7 OEM Engineer