Comprehensive Device Development Capabilities
How Can We Assist You?
Design and Development
Our consultants specialize in Human Factors/Usability, Combination Products (Devices / Drugs / Biologics), Electro-Mechanical and Sterile Disposables (FDA Class I, II and III).
We offer extensive industry experience regarding:
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Usability
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New Product Launch / Early Life Cycle Planning
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Design Controls
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Biocompatibility Assessment
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Design Assurance / Verification and Validation
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Safety Risk Management ISO 14971
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Sterilization / Cleaning Process Strategy and Validation
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RoHS Compliance
Usability
We can offer support or lead your project with a comprehensive usability solution utilizing the following specialties:
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Usability Product Design Audit
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Formative and Summative Testing
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Usability Study Design
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BS EN 62366:2008 and ANSI/AAMI HE75:2009
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Recruitment and User Screening
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Protocol/Report Development
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International Capabilities
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Custom Test Environments
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Professional Videography
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Usability Program Development
Example of studies we've performed include:
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Enteral Feeding Disposables
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Enteral Feeding Pumps
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Heart Bypass
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Angioplasty Catheters
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Introducers and Guide wires
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Sterile Disposable Tubing Sets
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IV Infusion Pumps
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Contrast Inujection
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Pharmaceutical Mixing
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User Interfaces
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Deep Brain Injection
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Labeling and Instructions