Medical Device Contract Packaging Services

We package a wide range of medical devices, including diagnostic tools, monitoring equipment, surgical accessories, and medical supply consumables. Our Cedar Park facility is equipped with proper storage and handling for sensitive regulated items, whether they arrive from US plants or overseas manufacturing hubs. Whether your product requires sterile pouching, tamper-evident seals, UDI marking, or retail-ready barcoded packaging, we accommodate your specific device category and US regulatory requirements.

Yes. Blue Bonnet Supplies provides FDA-cleared medical packaging. Our processes meet FDA standards for labeling, documentation, and packaging of regulated products, and we maintain ISO 13485 and GMP compliance across our facility. For cross-border exporters, your origin-market free-sale certificate supports US FDA establishment registration and device listing, so every package meets US medical device distribution requirements.

Yes, we offer sterile and compliant packaging specifically designed for medical devices that require it — sterile pouching that forms a clean barrier, tamper-evident seals, and a documented handling procedure. Our team ensures sterile packaging is processed correctly and documented properly to support your US compliance requirements, ideal for manufacturers who ship in bulk and need US-ready sterile packs on arrival.

Yes. Our kitting services assemble multiple medical device components or accessories into ready-to-ship kits tailored to your order specifications. Each kit is assembled accurately, labeled with FDA-compliant barcodes and UDI, and packaged securely. Available for single-order fulfillment and bulk runs, kitting and assembly let manufacturers ship components compact and have us build US kits for subscription boxes, bundles, or custom device sets.

Yes. Once your inventory reaches our US warehouse, we support Amazon FBA for medical supplies and devices — preparing inventory to Amazon's strict labeling and packaging requirements, storing products in our compliant facility, and shipping to fulfillment centers on your behalf. We handle FDA-compliant labeling, FNSKU barcode placement, and proper packaging so sellers' products are accepted without issue at Amazon warehouses.

Yes. We coordinate inbound air and ocean consolidation from overseas manufacturing hubs plus the US customs entry — CBP Form 5106, a customs bond, and a licensed broker, no US LLC required. Our team handles customs documentation, FDA-compliant import paperwork, and compliance checks to prevent delays, then ships domestically and onward internationally, using carrier relationships to reduce costs while your regulated products arrive safely and on time.

Returned medical devices go through our Product Testing and Restoration process at our Texas facility. Each item is inspected, tested for functionality, and evaluated against safety and usability standards. If it can be safely restored to sellable condition, we do so before returning it to your US inventory. This helps manufacturers and distributors recover value locally instead of shipping stock back overseas, while only compliant, functional products are resold.

Unlike large, impersonal 3PL providers, Blue Bonnet Supplies takes a personalized approach. We build customized packaging programs around how your business actually operates rather than forcing you into a rigid system. We specialize in regulated medical products — FDA, ISO 13485, GMP, and HIPAA-safe handling are built into daily operations, and we understand the bridge from origin-market clearance to US FDA listing. You'll work directly with a team that knows your products, your compliance needs, and is genuinely invested in your US success.