Our Services
Orivise delivers early-stage technical advisory for diagnostics and IVD development teams.
Services focus on feasibility evaluation, assay and bioconjugation risk reduction, and development readiness - combining deep scientific expertise with proportionate IVDR- and ISO 13485-aligned design-control awareness.
Independent technical judgement to determine whether an early assay or IVD concept is viable, identify key development risks, and define the appropriate next steps.
Includes:
• Feasibility and risk assessment
• IVDR-aware technical considerations
• Clear, actionable next-step recommendations
Best suited for teams with early concepts or preliminary data who require clarity before committing further investment.
IVD Concept & Feasibility Assessment
Targeted technical intervention to resolve high-risk issues affecting assay robustness, reproducibility, or conjugation performance.
Includes:
• Structured technical review
• Root-cause analysis
• Practical, risk-based mitigation guidance
Best suited for teams experiencing inconsistent, unstable or poorly reproducible assay performance.
Targeted Assay & Bioconjugation Troubleshooting
Strategic review to ensure early work is transferable, defensible, and aligned with early design-control expectations prior to formal development or technology handover.
Includes:
• Development-readiness assessment
• Early design-input structuring guidance
• Transfer-ready technical summaries
Best suited for teams preparing for internal development progression or external partner transfer.
Development Readiness & Feasibility-to-Transfer Support
Need clarity on whether your early-stage assay or IVD concept is ready to move forward?