​FDA-Accredited 510(k) Review

• We are accredited to review Class I/II IVD devices for Clinical Chemistry, Hematology, Immunology, Microbiology, Pathology, and Toxicology.
• We help our clients get their devices approved in ~65 days

See more

---

Consulting Services

Pharma, Biotech 

• Device strategy for biomarkers and precision medicine (PM)
• Guide decision making to pursue IVD manufacturer or LDT as CDx provider
• Qualify, negotiate, and manage third party laboratory and IVD partners ​​

Clinical Laboratories

• Guide startups from plan to operation, including obtaining required certifications and accreditation
• Direct CLIA labs with different specialties nationwide
• Enable established organizations to introduce new lines of service

Investors & Tech Appraisers

• Evaluate Diagnostics and Drug candidates for investment, asset prioritization, and mergers & acquisitions.
• Evaluate tech’s unmet need, landscape and market opportunities
• Guide establishing competitive product target profiles and pricing