Strict Quality Control Manufacturing, Quality First

Medicom Control Procedures of Taiwan and Thailand factories

At Medicom, our commitment to quality is not just a standard, but an unwavering promise we firmly believe in. Our production bases are located in Yilan, Taiwan, and Thailand,

Fully implement rigorous quality management to ensure every product meets the high-standard requirements of international stringent standards.

Comprehensive Quality Management System

We have established a comprehensive quality assurance process, covering the following four key stages:

Incoming Quality Control (IQC) — Strict inspection before raw materials enter the factory
In-Process Quality Control (IPQC) — Continuous monitoring during production
Final Inspection (FQC) — Comprehensive Quality Check Before Packaging
Outgoing Quality Control (OQC) — Final quality approval before shipment

All inspections are performed by professionally trained personnel in accordance with Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP), and are regularly subjected to random sampling and reliability testing to ensure consistent and stable product quality.

Product Design & Validation

Our product design and development validation strictly complies with:

• ISO 13485 Medical Device Quality Management System

• EN 868 and ISO 11607-1 Medical Sterilization Packaging Standards

With product safety, regulatory compliance, and ease of use as our core principles,

we deliver high-quality packaging solutions that meet medical requirements.

All inspections are performed by professionally trained personnel following

Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP),

with regular random sampling and reliability testing to ensure consistent

and stable product quality.

Material Selection & Testing

• All materials comply with ISO 10993 and ISO 11607-1 standards,

ensuring biocompatibility and structural integrity

• Medical-grade water-based inks for safety and environmental friendliness

Sterile Barrier Validation Support

We provide sterile packaging validation planning and technical advice to help

clients complete product validation efficiently, accelerating time-to-market

while ensuring regulatory compliance.

Clean Manufacturing Environment

All products are manufactured in controlled cleanroom environments with:

• Air curtains and isolation design at entry/exit points

• Segregated personnel and material flow paths

This design effectively reduces contamination risks, ensuring clean and safe

manufacturing processes that meet international cleanroom standards.

All products are produced in a controlled cleanroom environment and employ the following designs and measures:

Import/Export Curtain and Double Door Design
Separate personnel and logistics routes and implement one-way access control

This design can effectively reduce contamination risks, ensuring the cleanliness and safety of the entire process, meeting international cleanroom production standards.