Medical Device & Risk Assessment Services
Comprehensive evaluation of device and product safety.
We support device-enabled and combination products through targeted safety assessments and risk analysis.
What we provide:
- Device safety and performance evaluation
- Biocompatibility and toxicology planning
- Impurities, leachables, and excipient assessments
- In-silico genetic tox (Leadscope, N-nitrosamine CPCA)
- ISO/ICH-aligned risk mitigation strategies
Nikao’s Unique Value:
- Advanced modeling capabilities for impurity and genetic risk
- Strong regulatory alignment across device and drug requirements
- Holistic assessment across all product components