Comprehensive Device Development Capabilities

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).

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We offer extensive industry experience regarding:

• Usability

• New Product Launch / Early Life Cycle Planning

• Design Controls 

• Biocompatibility Assessment

• Design Assurance / Verification and Validation

• Safety Risk Management ISO 14971

• Sterilization / Cleaning Process Strategy and Validation

• RoHS Compliance

Usability

We can offer support or lead your project with a comprehensive usability solution utilizing the following specialties:

• Usability Product Design Audit

• Formative and Summative Testing

• Usability Study Design

• BS EN 62366:2008 and ANSI/AAMI HE75:2009

• Recruitment and User Screening

• Protocol/Report Development

• International Capabilities

• Custom Test Environments

• Professional Videography

• Usability Program Development

Example of studies we've performed include:

• Enteral Feeding Disposables

• Enteral Feeding Pumps

• Heart Bypass 

• Angioplasty Catheters

• Introducers and Guide wires

• Sterile Disposable Tubing Sets

• IV Infusion Pumps

• Contrast Inujection

• Pharmaceutical Mixing

• User Interfaces

• Deep Brain Injection

• Labeling and Instructions