Connecting You to the Market

The Challenge: Launch Delays Due to Packaging, Sterilization, and Logistics

Companies often focus their attention and resources on the complexities of product design and assembly. While these are critical, the final steps of finished device manufacturing can introduce costly risks:

• Packaging Delays: Improper sterile barrier design or validation issues can stall regulatory approvals and product launches.‍
• Sterilization Bottlenecks: Limited sterilization capacity, material incompatibility, or insufficient planning can cause weeks or months of delay.‍
• Labeling Errors: Incorrect or non-compliant labels can trigger recalls, audit findings, or lost market trust.‍
• Kitting & Logistics Gaps: Disorganized or fragmented processes increase costs and risk potential in multi-component kits.‍
• Warehousing & Distribution Challenges: Without integrated storage and shipping solutions, devices face longer lead times, higher costs, and potential quality issues.

Each of these issues may seem small compared to design, development, and assembly, but in reality, they often become the largest barriers to commercialization.

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Our Solution: Expertise in De-Risking the Entire Post-Assembly Process

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We provide end-to-end support for:

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Sterile Barrier Packaging

• Pouches, trays, blisters, and form-fill-seal systems designed and validated to ISO 11607 standards
• Process validation (OQ/PQ) and shelf-life studies to ensure compliance and durability

Kitting & Assembly Logistics

• Cleanroom kitting of multi-component devices and procedure packs
• Bulk packaging and custom configurations for distributor or hospital use

Labeling & Traceability

• Compliant and configurable labeling solutions tailored to customer and regulatory requirements
• Full traceability through our ISO 13485-certified QMS

‍Sterilization Management

• Expertise across EtO, gamma, and e-beam modalities
• Vendor coordination, compatibility testing, and cycle validation support with options for adoption

Warehousing & Distribution

• Integrated storage and shipping services from our North Carolina facility
• Streamlined logistics that reduce handoffs, costs, and lead times

Let Robling Connect Your Product to the Market with Quality and Efficiency

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