ADVANCING DIAGNOSTICS THROUGH COMPREHENSIVE DEVELOPMENT AND MANUFACTURING
- MRN Diagnostics
- Nov 7
- 2 min read
MRN Diagnostics is your trusted partner in all phases of development for your diagnostic, from feasibility to finished product.
We deliver complete solutions for diagnostic product design, development, and commercialization. Our capabilities extend across the entire product lifecycle, supporting your program from concept feasibility through large-scale manufacturing and post-market validation.
Quality, Compliance & Precision: Your Expert Partner
All MRN Diagnostics facilities are ISO 13485:2016 certified and operate under strict regulatory oversight, ensuring your products meet rigorous documentation and quality standards.
Explore our certifications, including our newly updated ISO 13485:2016 certification. |
Validation Designed for Your Assay’s Needs
We recognize the complexities of diagnostic development and validation, especially with emerging point‑of‑care technologies. That is why we offer untrained user studies, simulating real-world application scenarios, and in-depth validation testing that includes shelf-life, freeze/thaw, reproducibility assessments, and more.
Read more about our analytical testing capabilities to verify your diagnostic. |
OEM Manufacturing and Customized Biological Material
Developing an assay requires a partner who understands all phases of bringing a product to market. MRN Diagnostics offers custom design and development, beginning from feasibility planning to final product launch. Our high-end laboratories are specialized for large-scale bioproduction and manufacturing, providing you with a one-stop shop for bringing your diagnostic to market with precision and accuracy.
See how MRN Diagnostics can support your diagnostic development journey. |
When you partner with MRN Diagnostics, you gain more than a testing provider; you gain a collaborative team dedicated to your success. We integrate seamlessly with your development and manufacturing workflows to ensure validation meets all necessary regulatory expectations.
Contact us today at sales@mrndx.com to get connected and start the conversation. We are eager to work with you and your team.
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