User stories

User Stories: Specifying requirements for medical devices? Agile (software) developers frequently employ user stories to specify and document user requirements. Are this approach and this documentation compliant with regulatory requirements such as FDA’s software...

ISO 9241

The ISO 9241 Standards The ISO 9241 is an entire family of standards originally from the “Ergonomic requirements for office work with visual display units”. Meanwhile, the applicability of ISO 9241 has further developed to every form of product. Standards of the...

User Interface Design

User Interface Design (higher-level menu) We create wireframes and prototypes, interaction and design proposals while considering heuristic design principles We identify suitable methods to support the design process and iterative prototyping We develop style guides...

Usability Validation

Usability Validation: Compliant with IEC 62366 and FDA The usability validation is a test with objective means, whether the specified users can reach the specified user objectives (intended use) effectively and efficiently.  Regulatory requirements for the usability...