Custom Medical Device Packaging: Sterile Barrier, FDA Compliance & Clinical Kits (2026)

Medical Device Packaging: FDA 21 CFR 820 Compliance

The US medical device market reached $195 billion in 2025 (Fortune Business Insights). Every device touching a patient must be packaged in an FDA-compliant system maintaining sterility from factory to procedure.

Medical Device Packaging Formats

• Sterile barrier systems: Tyvek-lidded thermoformed trays. ISO 11607 compliant. Custom-molded to device geometry.
• Peel pouches: Tyvek/film pouches for small sterile devices. Self-seal or heat-seal.
• Folding cartons: Outer packaging with lot/expiry tracking, UDI labels, and IFU pocket.
• Clinical kit boxes: Custom rigid boxes for surgical kits with multiple compartments.

Regulatory Requirements

• FDA 21 CFR 820: Quality System Regulation for device packaging
• ISO 11607: Sterile barrier system requirements
• UDI labeling: Unique Device Identification on every package

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