Brochure | October 22, 2019

Integrated IVD Development Services

Source: Health Decisions Inc.

Health Decisions provides IVD developers with capabilities for streamlining clinical trials and reducing timelines and risk. Health Decisions’ integrated IVD development services offer the design and operational excellence, regulatory expertise and laboratory capabilities required to develop IVDs successfully and eliminate risk of delays in the 510(k) clearance or PMA review process. Our experience includes molecular diagnostics, immunoassays and other types of IVDs. Our capabilities for helping diagnostics companies make a rapid, successful transition from early sample-collection and validation studies to large subject-based studies are unmatched.

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