약학회지

ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 7.

Table. 7.

Identified risk and mitigation measures of EndeavorRx15)

Identified risk Mitigation measures
Ineffective treatment leading to worsening or uncontrolled symptoms • Labeling
• Clinical performance testing
Device software failure leading to delayed access • Labeling
• Software verification and validation
Treatment results in frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain • Labeling
• Clinical performance testing
• Software verification, validation, and hazard analysis
Treatment results in seizure • Labeling
• Clinical performance testing
Treatment results in screen addiction • Labeling
• Clinical performance testing
Treatment results in decreased sleep quality • Labeling
• Clinical performance testing
Yakhak Hoeji 2023;67:67-74 https://doi.org/10.17480/psk.2023.67.2.67
© 2023 Yakhak Hoeji