Our services for medical devices comply with:
- 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
- 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
- MotionLab in cooperation with Kiel University
- Full-scale Usability Lab
- 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.