Risk Management & Usability
Risk management according to ISO 14971 requires insight into the product and its intended use as well as knowledge of the regulatory requirements. VISAMED has successfully conducted risk analysis and risk mitigations for medical devices, including medical mobile apps.
VISAMED can provide training in risk management.
VISAMED plans and understands how users will interact with a medical device, through the graphical user interface or through other interfaces. We analyse the work-flow of the complete interaction between the user and the medical device. This analysis tightens the risk analysis (ISO 14971) and helps developing better products and better user interfaces.
VISAMED has implemented development processes according to IEC 62366 and the FDA guidance on applying human factors and usability engineering to optimise medical device design. Often, risk mitigations need to be in place to assure correct use and the user interfaces need to be designed appropriately in order to be accessible. VISAMED is an expert in the design of software and mobile apps for kids and elderly users and individuals with disabilities:
- Strategic user interface planning and implementation
- Early prototype testing
- Mockup screens and flow of action analysis
- User experience driven design
- Rapid Prototyping of Interfaces
- Integration of computer, mobile and web appearance