Clinical validation and trial support for in-vitro diagnostic devices, including study design, specimen management, data collection, and regulatory documentation.
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Carlsbad, CA, United States
DCN Dx, based in Carlsbad, California, is a global leader in IVD CDMO and CRO services, including clinical trials and regulatory services, specializing in the development of custom assays, consumables, and instruments for point-of-use applications. Our personalized approach to IVD product development has supported more than 650 programs from 300 clients.
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12 of 44 closest product alternatives
Harvest Integrated Research Organization (HiRO) · Taiwan
End-to-end clinical trial services for IVD products and medical devices, including study design, regulatory strategy, site management, and data analysis. Provides globally coordinated execution with biometrics-driven discipline and transparent oversight to accelerate clinical development and regulatory approval pathways.
Fujirebio Europe · Belgium
Clinical study design and execution services for diagnostic assay validation. Supports regulatory approval pathways for in vitro diagnostic devices.
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Comprehensive contract research and development services for in vitro diagnostic assays, including assay design, optimization, and validation. Supports development from concept through clinical implementation with regulatory guidance.
FirsTeck Bio Srl · Italy
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Shandong Lifei Biological Group Co., Ltd · China
Contract research organization services including clinical trial design, management, and execution for in vitro diagnostic devices. Supports regulatory compliance and data collection for product registration.
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Expert regulatory support for Class A through Class D IVD products including self-testing devices under IVDR 2017/746.
Meridian Bioscience - Life Science Divis · United States
In vitro diagnostic contract manufacturing services for diagnostic reagents and assay components under ISO13485 quality standards.
Chongqing JoinShare Pharmaceutical Technology Co.,Ltd. · China
Professional clinical trial management and execution services for medical devices, including protocol design, patient recruitment, data management, and regulatory documentation.
Rockland Immunochemicals, Inc. · United States
Comprehensive consulting and development services for creating successful in vitro diagnostic assays, including reagent selection and optimization support.
Nanjing Sigma Medical Technology Co., LTD · China
Comprehensive clinical trial services for medical devices including protocol design, statistical analysis, CRF design, informed consent preparation, clinical monitoring, data management, and statistical reporting. Services cover the entire clinical research process to support device registration and market approval.
Medix Biochemica Oy AB · Finland
Support for assay development and validation in diagnostic manufacturing. Provides expertise in quality assurance and regulatory compliance.
BBI Solutions OEM Limited · United Kingdom
Expert guidance on regulatory approval for diagnostic assays and reagent-based IVD products. Scientific data package preparation supports smooth regulatory submissions.
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