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Testimonials

Real feedback from diagnostic companies, biotech startups, and healthcare brands worldwide that have partnered with IVDCDMO for development, manufacturing, regulatory support, and scalable IVD commercialization solutions.
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Testimonials
IVDCDMO provided valuable support during our PCR reagent development and scale-up process. Their technical team demonstrated strong expertise in assay optimization, manufacturing consistency, and regulatory documentation management.
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Dr. Michael Turner
Director of Molecular Diagnostics, European PCR Diagnostics Company
As an early-stage point-of-care testing company, we required flexible manufacturing and practical technical support. IVDCDMO adapted well to our evolving production requirements and development timeline.
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Daniel Kim
Founder & CEO, Southeast Asia POCT Startup
We worked with IVDCDMO on IVDR-related manufacturing and compliance preparation for the European market. Their quality systems and regulatory coordination helped improve overall project efficiency and communication.
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Sophia Bennett
Regulatory Affairs Manager, In Vitro Diagnostics Company, Germany
Our project involved immunoassay reagent formulation and pilot-scale manufacturing. IVDCDMO maintained stable process control and responded professionally to technical modifications during production transfer.
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Olivia Carter
Senior Product Manager, Clinical Immunoassay Manufacturer
IVDCDMO supported our rapid diagnostic testing project with validation assistance, manufacturing planning, and technical communication. Their team maintained a practical and detail-oriented approach throughout the collaboration.
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Emily Richardson
Clinical Development Lead, Rapid Test Development Company
We selected IVDCDMO for OEM manufacturing support of several molecular diagnostic products. Their documentation management, production coordination, and quality consistency met our expectations for international distribution.
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James Walker
Vice President of Operations, North American Molecular Diagnostics Brand

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Frequently Asked Questions

Find answers to common questions about IVDCDMO services, including IVD product development, OEM manufacturing, regulatory support, quality management, pilot production, and international diagnostic commercialization solutions.
What services does IVDCDMO provide?
IVDCDMO provides end-to-end IVD CDMO services including assay development, reagent formulation, OEM/ODM manufacturing, pilot production, quality management, regulatory support, and commercial-scale manufacturing.
What types of IVD products do you support?
We support a wide range of in vitro diagnostic products including PCR reagents, molecular diagnostics, POCT products, immunoassays, clinical chemistry reagents, rapid test kits, and customized diagnostic solutions.
Do you support OEM and private label manufacturing?
Yes. We provide flexible OEM and private label manufacturing services for global IVD brands, distributors, laboratories, and healthcare companies.
Can you assist with IVDR and international regulatory compliance?
Yes. Our team supports regulatory documentation, quality systems, and compliance preparation for international markets including Europe, North America, and other global regions.
Do you work with startups and early-stage biotech companies?
Yes. We support both startups and established diagnostics companies with flexible development and manufacturing solutions tailored to different project stages and production volumes.
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