Diagnostic Device Manufacturing—A Full-Service Approach from Prototype to Production

Diagnostic Device Manufacturing—A Full-Service Approach from Prototype to Production

Diagnostic Device Manufacturing—A Full-Service Approach from Prototype to Production

The global demand for diagnostic devices has surged, driven by advances in point-of-care testing, home health solutions, and precision medicine. From rapid COVID-19 test kits to sophisticated lab-on-a-chip systems, diagnostic technologies are transforming how healthcare is delivered. But bringing a diagnostic device from idea to market takes more than innovation—it requires a manufacturing partner who understands both science and compliance.

At Ciro Manufacturing, we specialize in end-to-end diagnostic device manufacturing, combining in-house tooling, cleanroom molding, reagent filling, and regulatory-aligned assembly under one ISO 13485-certified roof.

What Is Diagnostic Device Manufacturing?

Diagnostic devices are tools used to detect diseases, monitor biomarkers, or guide treatment decisions. These include:

  • Rapid test kits (antigen/antibody)

  • Sample collection and transport devices

  • PCR and molecular testing cartridges

  • Blood glucose and pregnancy tests

  • Lab-on-a-chip platforms

Manufacturing these products involves multiple integrated disciplines, including plastic molding, reagent filling, sterile kitting, labeling, and traceable packaging.

Why Manufacturing Matters in Diagnostics

The performance of a diagnostic device isn’t just determined in the lab—it’s shaped on the manufacturing floor. Quality, repeatability, and regulatory compliance directly affect:

  • Clinical accuracy and reproducibility

  • FDA/CE approval timelines

  • Cost per test and scalability

  • Brand reputation and market trust

Ciro helps diagnostics companies bridge the gap between concept and commercialization with a vertically integrated model that reduces risk and accelerates time to market.

Our Diagnostic Manufacturing Capabilities

1. Mold Design & Injection Molding

We create custom molds for components like:

  • Test housings

  • Fluid reservoirs

  • Sample collection tools

  • Microfluidic channels

Our high-precision molding equipment supports medical-grade polymers like COC, PC, PP, and ABS. All parts are produced under documented, ISO 13485-controlled conditions.

2. Cleanroom Assembly (ISO Class 6)

Sterile or semi-sterile assemblies are built in our ISO-certified cleanroom. Applications include:

  • Assembly of lateral flow devices

  • Cartridge housing assembly

  • Foil sealing and protective barrier applications

3. Liquid Filling & Reagent Handling

We fill diagnostic reagents such as buffers, enzymes, stabilizers, and controls using:

  • Sterile liquid filling lines

  • Volume precision from 0.5 mL to 100 mL+

  • Lot-controlled production with documentation for FDA/CE submission

4. Private Label Kitting & Packaging

From single-test pouches to bulk lab kits, we provide custom packaging:

  • Printed IFUs and branded cartons

  • Tamper-evident sealing

  • Barcoding and lot coding

Regulatory Readiness Built-In

Our ISO 13485-certified QMS ensures every step of production is validated and traceable. Clients benefit from:

  • Full DHR (Device History Record) documentation

  • Material traceability and lot control

  • Documented SOPs and CAPA protocols

We support clients preparing for:

  • FDA 510(k) or EUA submissions

  • EU IVDR and MDR compliance

  • Clinical trial sample kit prep

Case Study: From Prototype to Market-Ready COVID-19 Test Kits

In 2020, a diagnostics company needed to scale up production of a lateral flow COVID-19 test kit. Ciro provided:

  • Mold design and tooling in 2 weeks

  • Cleanroom molded cassettes and collection swabs

  • Liquid reagent fill and sealed kit kitting

  • FDA EUA-aligned documentation

The result? Over 2 million units shipped within 10 weeks—ready for clinical deployment.

Who We Serve

Our diagnostic device clients include:

  • Startups bringing a new technology to market

  • Established medtech companies seeking reliable domestic manufacturing

  • Research institutions launching point-of-care tools

Final Thought: Your Innovation, Our Infrastructure

The diagnostic market is evolving fast—and the manufacturers that support it must be faster, smarter, and deeply rooted in regulatory best practices. At Ciro Manufacturing, we bring your diagnostic device to life with precision, speed, and compliance you can count on.

👉 Contact us today to discuss your next diagnostic product or pilot program.

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