Contract Manufacturing | MRN Diagnostics

From Concept to Kit: Contract Manufacturing You Can Trust

MRN Diagnostics offers full-service contract manufacturing solutions for Point-of-Care Testing (POCT), In Vitro Diagnostics (IVD), and Research Use Only (RUO) products. Our end-to-end capabilities are designed to streamline your path from concept to commercialization, delivering reliable, high-quality products with efficiency and precision. Whether you need formulation support, flexible kitting options, or advanced quality control, our experienced team is ready to meet your manufacturing needs with scalable solutions and regulatory expertise.

Custom Formulation & Reagent Preparation

We develop and produce assay-specific reagents tailored to your performance requirements, ensuring consistency and stability across production batches.

Kitting, Packaging & Assembly

From single-use kits to complex multi-component configurations, we handle all aspects of kitting and packaging to meet your design and branding needs.

Biorepository & Controlled Storage

We maintain proper storage conditions, including chain of custody and ambient environments, to preserve product integrity.

Analytical & Validation Testing

Our analytics team provides robust testing to verify assay performance, stability, and lot consistency, supporting regulatory and quality assurance requirements.

Custom Quality Control & Quality Assurance

We design and implement Quality Control/Quality Assurance protocols specific to your product, ensuring each batch meets exacting standards before release.

Why Choose MRN Diagnostics?

MRN Diagnostics is your trusted partner in delivering high-quality, custom diagnostic solutions. With a foundation built on scientific precision and responsive collaboration, we offer comprehensive manufacturing services that support your product from concept to commercialization. Our team brings extensive experience in developing and producing controls, panels, and finished diagnostic kits for point-of-care testing (POCT), in vitro diagnostics (IVD), and research-use-only (RUO) applications.

What sets us apart is our commitment to quality and compliance. We operate under a robust quality management system and adhere to ISO 13485:2016 standards, ensuring every product meets stringent regulatory and performance requirements. From design controls and technical documentation to batch release and traceability, our processes are built to support your regulatory pathway with confidence.

Our dedicated QA/QC teams work closely with you to tailor validation, verification, and stability testing protocols to your specific needs, providing full transparency and consistent quality at every stage. Whether you’re preparing for FDA submission, CE marking, or internal R&D milestones, MRN Diagnostics offers scalable, compliant manufacturing that you can rely on.

Choose MRN Diagnostics for a partnership rooted in integrity, innovation, and end-to-end support.

From Idea to Impact: Let’s Do it Together

Whether you’re looking to scale production, develop custom controls, or streamline your diagnostic workflow, our team is here to help. Submit a request for a quote or contact us directly—we’re happy to answer your questions and explore how we can support your manufacturing needs.

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