Optimized Analytical and Engineering Solutions
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Custom Fluorescence Detection Systems: Proof-of-concept through product launch
Custom Fluorescence Detection Systems: Proof-of-concept through product launch
Optimized to balance your priorities:
Optimized to balance your priorities:
Multiplexed and multichannel systems
Imaging and light quantitation
Sensitivity/Signal-to-noise
Cost of goods
Ease of use
Sample considerations
Assay Development: Proof-of-concept through product launch
Assay Development: Proof-of-concept through product launch
IVD and CDx assays
IVD and CDx assays
Microbead-based assays:
Microbead-based assays:
Custom bead design (multiplex dying, surface coating, etc.)
Antibody quantitation (serology) assays
Antigen quantitation
Cell-based assays:
Cell-based assays:
Reagent selection and optimization
Cross-talk reduction
Sample preparation
Technical Risk Analysis and Mitigation Strategy
Technical Risk Analysis and Mitigation Strategy
Technology Evaluation and Due Diligence
Technology Evaluation and Due Diligence
Extensive experience developing and maintaining clinical IVD products
Extensive experience developing and maintaining clinical IVD products
Design control
Risk management
System Architecture
Requirements traceability
Verification and validation testing design
Regulatory submissions: FDA, CE, cFDA, WHO prequal
Audit support
Fluorescence image processing and analysis
Fluorescence image processing and analysis
Software/firmware management, architecture and programming
Software/firmware management, architecture and programming
Statistical analysis, test design, and estimation
Statistical analysis, test design, and estimation
Data modeling, non-linear data fitting and parameterization
Data modeling, non-linear data fitting and parameterization
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