Our services for medical devices comply with:
Standards
  • IEC 62304:2006
  • IEC 62304:2006 Amd 1:2015
  • IEC 62366:2007
  • IEC 62366:2007 Amd 1:2013
  • IEC 62366-1:2015
  • IEC TR 62366-2:2016
  • ISO 14971:2007 / EN ISO 14971:2012
  • ISO 13485:2016 / EN ISO 13485:2012
  • AAMI TIR 45
FDA Guidances
  • General Principles of Software Validation
  • Content of Premarket Submissions for 
Software Contained in Medical Devices
  • Content of Premarket Submissions for 
Management of Cybersecurity in 
Medical Devices
  • Off-The-Shelf Software Use in Medical Devices
  • Applying Human Factors and 
Usability Engineering to Medical Devices

Infrastructure

  • MotionLab in cooperation with Kiel University
  • Full-scale Usability Lab
Benkana-User-Pool
  • Age and Gender
  • Profession (focus: health care professionals)
  • Personality traits that define the user acceptance of your innovations
  • Anthropometry and Biomechanics
  • Body strength
  • Transpiration and microclimate
  • Full service: Recruitment, Payment and Legal Framework

Intelligent Anthropometry and Biomechanics for Benkana Interfaces

  • We analyse our extensive world-wide databases for anthropometry and biomechanics to define the relevant physical characteristics of your user group.
  • We translate the identified relevant standard data into physical characteristics of your product.
  • We select 8-12 subjects that represent the physical characteristics of your (worldwide) user group from our Benkana-User-Pool.
  • We conduct an prototype evaluation in the MotionLab and derive substantial product improvements based on comparable and dependable data.
  • Your benefit: Be sure your product fits humans – worldwide.

The next steps

Training

You want to learn more? Usability Engineering, Requirements, Ergonomics, Medical Device Software are our topics. Visit one of our public trainings! Should we deliver an inhouse-training at your company? Contact us and we find a way to help you!

Gap-Analysis

Your team develops medical devices to the best of their knowledge and judgement? You still think that you can be more efficient? Or you have the slight feeling that not everything is as it should be? Get in touch with us and we conduct a gap-analysis e.g. using IEC 62304, FDA Guidances or Medical SPICE.

Strategy
Workshop

You have technically advanced and high-quality products, real innovations? Still users struggle with your products? Or is your product hard to handle or uncomfortable? Talk to us about a strategy workshop! Together with you we develop the right action plan to make your products attractive and usable.