​Diagnostics

• Help our clients develop, validate & register IVD devices under different classes
• Assess market demand, barriers to entry, and device/technology competitiveness
• Guide product target profile, risk analysis, and implementation of risk mitigation plans
• Consult on technology proof-of-concept, validation/verification, qualifications (DQ, IQ, OQ, PQ), and overall quality management system
• Advise on engagement with pharma/biotech and CRO for utilization of diagnostic devices in clinical trials or for CDx projects