Medical Device Kitting and Packaging—Precision, Compliance, and Market Readiness
For medical device manufacturers, delivering a great product is only part of the equation. How it's assembled, packaged, and presented can directly influence regulatory approvals, clinical outcomes, and user confidence. That’s why medical device kitting and packaging must meet the same standards of quality and traceability as the device itself.
At Ciro Manufacturing, we offer turnkey medical kitting and packaging services under ISO 13485-certified systems—giving our clients confidence in both performance and presentation.
What Is Medical Device Kitting and Packaging?
Medical kitting is the process of assembling multiple components—such as test devices, sample collection tools, instructions, and reagents—into a single, ready-to-use package. Packaging ensures those components are protected, traceable, and compliant with labeling and regulatory requirements.
These kits can include:
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Diagnostic or screening kits (e.g., rapid test kits)
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Surgical or procedural instrument sets
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Specimen collection kits (swabs, tubes, transport media)
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Home-use and clinical trial kits
Our Medical Kitting & Packaging Capabilities
1. ISO Class 6 Cleanroom Kitting
We build kits in a contamination-controlled environment:
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Swab and tube assembly
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Test housing, reagents, and components configured to spec
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Visual inspection and inline QC at each step
2. Custom Labeling and Branding
We offer:
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Private-label and OEM branding
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UDI-compliant labels
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Barcode and serialized tracking
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Expiration dates and lot numbers
3. Regulatory-Ready Documentation
Each kit includes:
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Device History Records (DHRs)
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Certificate of Conformance (CoC)
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Traceability logs from batch to shipping
4. Flexible Packaging Options
We support:
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Pouch, clamshell, and blister pack formats
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Cold chain packaging and stability planning
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Insert and IFU printing and folding
Why It Matters: More Than a Box
In healthcare, packaging isn’t just about appearance—it protects sterility, improves usability, and provides essential regulatory documentation. Poor kitting can lead to:
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User confusion
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Compromised test accuracy
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Regulatory rejections
Our processes ensure medical kits arrive ready for clinical or consumer use with no gaps in compliance.
Case Study: Diagnostic Collection Kit for Nationwide Lab Network
A national lab chain needed 250,000 diagnostic sample collection kits in under 6 weeks. Ciro provided:
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Cleanroom assembly of swabs, vials, and instructions
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Individual pouching and barcode tracking
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Palletized distribution-ready packaging
The kits were delivered on time, passed inspection, and supported over 1 million tests.
Final Thought: Packaging That Completes the Product
At Ciro Manufacturing, we treat kitting and packaging as an extension of your product—not an afterthought. Our ISO 13485 systems, cleanroom operations, and attention to detail ensure that your medical kits arrive accurate, sterile, and ready for real-world use.
👉 Contact us today to streamline your next medical device kit.
