Consulting Services for Diagnostics & IVDs

Diagnostic tools guide treatment decisions and must meet stringent regulatory, compliance, and quality standards to ensure their accuracy and reliability. To ensure effective adherence to these requirements, choose Validant.

Putting Test Tubes Into The Holder Of Analyzer Machine

Specialists in In Vitro Diagnostics

Validant’s subject matter expertise in global regulatory, compliance, and quality requirements for IVDs spans:

  • Molecular Diagnostics
  • Immunoassays
  • Laboratory Tests
  • Companion Diagnostics
  • Point of Care Tests
  • Genomics and Proteomics
  • At-Home Tests

We have also already helped numerous clients prepare for the new EU IVDR legislation’s coming changes. Learn how we can help you ensure a smooth transition to keep your products compliant and on the European market.

diagnostic tools regulatory compliance

Diverse Expertise in Diagnostic Tools

Our team has worked with a diversity developers and manufacturers creating innovative tools including:

  • Medical Diagnostic Equipment
  • Tissue Systems and Technologies
  • Cell Imagers
  • Molecular Analysis Tools
  • Robotics/Liquid Handling Systems
  • Sequencers and Microarrays

Whether supporting the launch of a new platform, defining the right commercialization strategy for innovative new equipment, or managing through recall crisis, Validant provides practical and hands-on guidance at every phase of the product lifecycle.

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