TEAM NB pub­lished ques­tion­naire on AI in med­ical devices

The Euro­pean asso­ci­a­tion for noti­fied bod­ies, TEAM NB, recent­ly pub­lished a Q&A doc­u­ment on arti­fi­cial intel­li­gence (AI) in the con­text of med­ical devices. The doc­u­ment con­tains ques­tions rel­e­vant for review­ers who eval­u­ate AI in devices. Please note the doc­u­ment should rather be seen as a guid­ance doc­u­ment for ques­tions that an asses­sor will ask with the cor­re­spond­ing reg­u­la­to­ry sources.

The ques­tion­naire can be accessed here.

Source: TEAM NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website