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3335 Tuscarawas Rd
Beaver, PA 15009

+1 412 418 8066

info@qaraconsultinggroup.com

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Contact us today to learn how QA/RA Consulting Group can 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).

Usability

Contact us today to learn more about how QA/RA Consulting Group can assist you.

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

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

We have extensive experience with the following studies:

  • Enteral Feeding Disposables

  • Enteral Feeding Pumps

  • 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