In Vitro Diagnostic (IVD) Platform Engineering

Helping you lead the way in high-performance immunoassays and analytical platforms for precision in vitro diagnostics.

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Immunoassay Technologies for Cutting-Edge In Vitro Diagnostics

Advancements in materials science, miniaturization, and scalable manufacturing are redefining the design and deployment of immunoassays. Nanoparticle-enabled assays are improving analytical sensitivity for low-abundance analytes. To support high-throughput laboratory workflows, assay consumables integrate seamless automation. Plastic consumables are evolving into functional microfluidic systems that allow for multiplexing and reduced sample and reagent volumes. 

In parallel, sustainability is gaining importance in assay consumable design, with growing exploration of recyclable and biodegradable polymers for single-use formats. 

Accelerating Commercialization of Your Immunoassay Platforms

Backed by decades of experience, Syrma Johari MedTech helps in vitro diagnostic (IVD) companies drive successful innovation in high-sensitivity immunoassay platforms. Our strength lies in our deep technical know-how and advanced tools and technologies that deliver custom assay formats and multiplex platforms with reproducibility at scale.

01
Immunoassay Consumables & Cartridge Manufacturing
  • Design and manufacturing of plastic-based immunoassay consumables
  • Functional microfluidic features: channels, chambers, valves, reagent reservoirs
  • Singleplex and multiplex assay systems
  • Tight dimensional and process controls for lot-to-lot consistency
  • Integration with automated immunoassay analyzers
  • Design optimization for robotic handling, fluid dispensing, and incubation
02
Materials & Polymer Expertise
  • Selection and processing of high-performance polymers (COP, COC, medical-grade thermoplastics)
  • Design for optical clarity, low autofluorescence, and signal integrity
  • Material compatibility with fluorescence, chemiluminescence, and colorimetric detection
  • Consideration of biocompatibility, chemical resistance, and thermal stability
  • Sustainable polymer alternatives for single-use consumables

Simplifying Your Product Journey from Sketch to Launch

We seamlessly integrate our solutions to translate your concepts into market-ready immunoassay devices. With comprehensive capabilities in design, manufacturing, and regulatory support, we reduce time to market and sustain market competitiveness for your product.

Advanced Manufacturing Capabilities
  • Precision plastic molding for immunoassay consumables and cartridges
  • ISO Class 8 cleanroom manufacturing
  • ISO class 7 cleanroom assembly
  • 3D printing and rapid prototyping of custom assay formats and microfluidic chips
  • Low to high volume production

As an ISO 13485–certified medical device CDMO, our robust quality systems comply with MDSAP, U.S. FDA, and other international regulations for smoother market entry.

  • Detailed documentation (FDA, EU IVDR, and other regional regulations)
  • Process validation, end-to-end traceability, and change management
  • End-to-end support from global regulatory submissions to post-market sustenance

Beyond Functionality: Engineering Regulatory Resilience into Next-Gen IVD Platforms

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Unparalleled Precision & Accuracy in Diverse Applications

  • Clinical Diagnostics
  • Point-of-Care and Decentralized Testing
  • Women’s Health and Fertility Testing
  • Therapeutic Drug Monitoring and Toxicology
  • Research and Companion Diagnostics

Partner with the Best

Streamline your immunoassay product journey from concept to commercialization with our unmatched technical expertise and advanced technologies.

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