Risk Management & Usability

Risk Management

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.

Human–Computer Interaction

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