In today’s highly regulated healthcare industry, safety, consistency, and compliance are non-negotiable—especially when it comes to medical device packaging. That’s why ISO 13485 certification is a vital benchmark for manufacturers who serve the global medical market.

We are proud to be an ISO 13485 certified medical packaging manufacturer based in China, offering custom disposable blister trays and thermoformed packaging for a wide range of medical devices.

🔍 What Is ISO 13485?

ISO 13485 is an internationally recognized standard that defines the requirements for a comprehensive quality management system (QMS) for the design and manufacturing of medical devices and related services.
It focuses on:

• Risk management

• Sterility assurance

• Process validation

• Regulatory compliance (e.g., EU MDR, FDA 21 CFR)

For our customers, this certification means you’re partnering with a factory that meets strict quality, traceability, and hygiene standards.

🏭 Our Capabilities

With cleanroom facilities, advanced thermoforming equipment, and over [X] years of experience, we deliver custom packaging solutions for:

• Surgical instruments

• Diagnostic kits

• Catheters and tubing

• IV sets and injection tools

• Single-use medical devices

We use medical-grade PET, PETG, PS, and PVC materials, and offer packaging options compatible with Tyvek sealing, EtO sterilization, and anti-static properties.

🤝 Why Work With Us?

• ✅ ISO 13485 Certified QMS

• 🧪 Tailored Designs & Rapid Prototyping

• 🧼 Class 100,000 Cleanroom Manufacturing

• 🌍 Proven Export Record to EU, U.S., Asia-Pacific

• 📦 Low MOQ & Fast Turnaround Times

We understand the importance of every detail in medical packaging—from material safety to perfect fit and sterile sealing. Our goal is not just to supply packaging, but to protect your brand and support patient safety.