COVID-19: Medical Device and Diagnostic Solutions

From in vitro diagnostic test kits to critical care devices and remote monitoring technologies, COVID-19 caregivers and patients rely on a wide range of devices and diagnostics, highlighting the urgent need for accelerated development.

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Supporting you device and diagnostic development needs for COVID-19

At any stage in your product lifecycle, our dedicated medical device development team provides strategic consulting, infectious disease experience and an integrated development model that brings the combined testing and trial capabilities of Labcorp to your program.

 Now’s the time to advance your COVID-19-related medical products and make a difference for patients and providers.  

Regulatory guidance for rapid development and emergency use possibilities

Expedited consultation for Emergency Use Authorization (EUA) for your assay or medical device. We offer validation capabilities and regulatory guidance to support review with the FDA.

Expedited strategies to accelerate infectious disease-related products

Benefit from our infectious disease experience by working with medical device and diagnostic specialists to proactively plan an expedited development path for your COVID-19 medical product.

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Integrated development for combination products including vaccines & IVD kits

Realize efficiencies by aligning the development of your device and therapeutic in a single development program. Accelerate your path through preclinical, clinical and post-market stages.

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COVID-19-related devices and diagnostics make a difference throughout the patient journey

Work with a trusted partner to support the development of your COVID-19-related medical products, which can include: 

  • Airway and pulmonary management devices (e.g., ventilators, nebulizers, inhaled drug delivery systems)
  • Hemofiltration and dialysis devices
  • Infusion systems and administration sets
  • Novel applications: AI-powered diagnostics, UV light-administering devices
  • Sample collection devices: nasal swabs, blood draw devices
  • Safety applications (e.g., personal protective equipment (PPE))
  • Remote monitoring applications: pulse oximeters, touchless thermometers
  • Diagnostics: testing kits, antibody assays, imaging technologies
  • And more… connect with us to see how we can help  

Streamline your COVID-19-related device development – for fast, insightful execution

Trim your development timelines with a single program that interlaces connected insights and expert delivery to yield development efficiencies at every stage of your product’s life cycle, including:

  • Consulting: Enable your development plan with regulatory, quality, health economic, reimbursement and clinical strategies, interlacing every stage of development
  • Preclinical: Demonstrate device safety and performance with biocompatibility testing and experimental surgery
  • Clinical: Conduct pilot and pivotal trials in clinical and decentralized settings, generating the safety and efficacy data needed to drive regulatory approval
  • Post-market: Maximize commercial success with comprehensive patient support, product vigilance and other post-market services such as audits and obsolescence 

Apply proven experience to ensure an integrated approach for your device or diagnostic. Together, we can help you reach patients faster. 

Connect with our COVID-19 Response Team

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