IVD and Medical Device Clinical Trial Services
Accelerate Your Path to Market with a Proven IVD and Medical Device CRO
CovarsaDx supports diagnostics and medical device companies with expert-led clinical trials from early feasibility through FDA clearance.
Why CovarsaDx?
End-to-end clinical trial management for IVDs and medical devices
Regulatory expertise in PMA, 510(k) and De Novo
Agile and audit-ready operations
Tailored, personalized approach
Our Services
Clinical Research:
- Study design
- Protocol development
- Site selection and monitoring
- Data management and EDC systems
- Verification and Validation
Regulatory Affairs:
- Submission strategy (PMA, 510(k), De Novo)
- Gap assessments and FDA readiness
- Labeling Compliance
- Biocompatibility Assessments and Strategy
Quality Assurance:
- GCP compliance audits
- Quality systems consulting
- Vendor qualification
Results That Matter
“Through our partnership with CovarsaDx, we were able to leverage their extensive clinical expertise and resources from meticulous study planning to execution.”
-Bryan Fang, president of Healgen Scientific, LLC on CovarsaDx’s support to Healgen’s at-home COVID-19 and Influenza test achieving FDA de Novo Status