Packaging

Medical Device Packaging Solutions

Engineered for Sterility. Designed for Speed. Validated for Success.

At Eagle Medical, we design, develop, and deliver sterile barrier packaging systems that accelerate time-to-market, ensure regulatory compliance, and protect your product from factory to field.

From pre-validated solutions to fully customized configurations, our ISO-certified cleanroom packaging services are tailored to meet the exacting needs of today’s medical device innovators. Whether you’re launching a new device or optimizing an existing design, our in-house engineers and packaging specialists can help you navigate materials, sealing technologies, testing protocols, and documentation requirements with precision, speed, and confidence.

Advanced Packaging Capabilities

We offer a comprehensive range of packaging formats and materials, all developed in-house and produced in our ISO Class 7 cleanrooms:

• Thermoformed trays with integrated seal flanges for robust protection and efficient sealing

• Pouch systems featuring Tyvek®, multi-layer films, and custom geometries

• Custom die-cut backer cards, inserts, and shields for sharp or fragile instruments

• Form-fill-seal, shrink-wrap, and kitting solutions for streamlined workflows and sterile field performance

• Device-matched packaging design using proxy units and risk-based testing to ensure system integrity

True-Validated™ Packaging Systems

Reduce timelines from months to weeks. No compromise.

Our True-Validated™ packaging platforms offer a faster, smarter alternative to traditional custom builds. These pre-validated systems come with:

• Complete documentation sets (IQ/OQ/PQ, material certs, test data)

• Compatibility with a wide range of device types and sterilization methods

• Regulatory support for FDA, ISO, and EU submissions

• Full traceability and repeatability for audits and inspections When appropriate, we also support hybrid models, leveraging validated trays and pouches while customizing internal configuration for a perfect device fit.

Design, Testing & Validation Support

Eagle Medical provides integrated support across every stage of the packaging lifecycle:

• Packaging design optimization aligned with device geometry and clinical use

• Material selection consulting based on performance, cost, and regulatory factors

• Preliminary and formal packaging validations, including ASTM D4169, ASTM F1980, ISO 11607-1/2, and ISTA protocols

• Sterilization compatibility mapping for EtO, VH₂O₂, steam, and other methods

• Ongoing engineering support through design freeze, verification, and launch

Regulatory Confidence Built In

All Eagle packaging solutions are developed in compliance with:

• ISO 11607-1 and ISO 11607-2 (Sterile Barrier Systems)

• ASTM F1929 (seal integrity testing)

• ISO 13485 (Medical Device QMS)

• FDA 21 CFR 820

• Other relevant ASTM, ISTA, and ISO standards as required Our team can provide all documentation needed for successful regulatory submissions in the U.S., EU, and global markets.

From Design to Delivery, Faster Than You Thought Possible

With Eagle Medical as your partner, you gain more than a packaging vendor. You gain a strategic resource with deep expertise in medical device requirements, sterilization pathways, and regulatory demands. Our agility, validation-ready systems, and cross-functional engineering support help you move from concept to commercialization in record time.

Let’s package your success.