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BLACKHAGEN-DESIGN INC

DUNEDIN, Florida, USA

  • Establishment Year :1995
  • Trade Name :
  • Contact Person :PHILIP REMEDIOS
  • Address :333 SCOTLAND ST, DUNEDIN, FLORIDA-34698-6960
  • Phone : 727-736-0582
  • Fax :727-738-0523
  • Website : www.blackhagendesign.com
  • Capabilities :BlackHägen Design (BH) is a cross-disciplinary strategic research & product development firm. With a user-centered approach to product definition & design development, BH offers valuable, proven & efficient R&D methodologies to achieve optimized design solutions. We have performed Contextual Inquiry and Usability Engineering projects in 20 countries, including North America, Europe & Asia-Pacific. BH has played a critical role in minimizing failure modes associated with usage error through intuitive user interface design.By developing & deploying kinematic test models & immersive research techniques in global ethnographic studies, BH maximizes the usability of disposable devices & electro-mechanical systems while minimizing use-error & procedural cost, enhancing clinical procedures & the continuum of care. BH has a documented history developing Class I, II & III medical devices while supporting FDA/QSR, ISO 13485 & AAMI guidelines for good design practices & quality assurance.

  • Quality Assurance Standards

    • ANSI/ASQC Z1.4 Certification : NO
    • ISO-9000 Certification : YES
    • ISO 10012-1 Certification : NO
    • MIL-Q-9858 Certification : NO
    • MIL-STD-45662A Certification : NO

Products & Services Offered by BLACKHAGEN-DESIGN INC

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