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:

  • 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

Need Usability Study Support?

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