Diagnostic Partnerships and OEM Solutions

Supporting Your Diagnostic Assay Development and Workflow Needs

Are you looking for support for your diagnostic assay development or a customized solution for your sample preparation workflow? Through STEMCELL’s Diagnostic Partnerships and OEM Solutions program, we can work with you to streamline your processes and develop robust and customized sample preparation solutions to meet your specific needs. Our qualified experts are ready to provide you with the best solution for your workflow, whether it’s collaborating to register an existing product as an in vitro diagnostic (IVD) device, or partnering with you through an original equipment manufacturer (OEM) agreement with our experienced technical and regulatory support.

With over 15 years of experience working with global regulatory bodies, including the US Food and Drug Administration (FDA), Health Canada, and the European Commission (for establishing compliance to the In Vitro Diagnostic Medical Device Regulation (IVDR)), you can trust that STEMCELL can help you achieve your goals and meet the standards required within the diagnostic industry.

Personalized Support and Tailored Solutions

Why Partner with Us?

  • Work with experts who have supported industries through clinical collaboration, commercialization, and regulatory submissions.
  • Get support from a team that has partnered with several customers worldwide to meet their country and region-specific requirements.
  • Leverage our diverse range of products and scalable solutions to optimize your processes.
  • Connect directly with our experienced scientists and dedicated service manager to achieve your goals.
  • Achieve a customized workflow to meet the specific needs of your laboratory.
Contact Diagnostic Partnerships and OEM Solutions

Have Questions or Want to Learn More?

Navigate complex regulatory requirements and collaborate with us to streamline your workflow, with the expert support of our Diagnostic Partnerships and OEM Solutions team. Contact us below to start the conversation.

Support for Your Regulatory and Compliance Needs

Explore this resource page to learn more about how STEMCELL can work with you to meet compliance requirements, and access relevant documentation.

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Additional Resources