Π£ Π½Π°Ρ Π²Ρ ΠΌΠΎΠΆΠ΅ΡΠ΅ ΠΏΠΎΡΠΌΠΎΡΡΠ΅ΡΡ Π±Π΅ΡΠΏΠ»Π°ΡΠ½ΠΎ Benefit-Risk Requirements in EU-MDR ΠΈΠ»ΠΈ ΡΠΊΠ°ΡΠ°ΡΡ Π² ΠΌΠ°ΠΊΡΠΈΠΌΠ°Π»ΡΠ½ΠΎΠΌ Π΄ΠΎΡΡΡΠΏΠ½ΠΎΠΌ ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅, Π²ΠΈΠ΄Π΅ΠΎ ΠΊΠΎΡΠΎΡΠΎΠ΅ Π±ΡΠ»ΠΎ Π·Π°Π³ΡΡΠΆΠ΅Π½ΠΎ Π½Π° ΡΡΡΠ±. ΠΠ»Ρ Π·Π°Π³ΡΡΠ·ΠΊΠΈ Π²ΡΠ±Π΅ΡΠΈΡΠ΅ Π²Π°ΡΠΈΠ°Π½Ρ ΠΈΠ· ΡΠΎΡΠΌΡ Π½ΠΈΠΆΠ΅:
ΠΡΠ»ΠΈ ΠΊΠ½ΠΎΠΏΠΊΠΈ ΡΠΊΠ°ΡΠΈΠ²Π°Π½ΠΈΡ Π½Π΅
Π·Π°Π³ΡΡΠ·ΠΈΠ»ΠΈΡΡ
ΠΠΠΠΠΠ’Π ΠΠΠΠ‘Π¬ ΠΈΠ»ΠΈ ΠΎΠ±Π½ΠΎΠ²ΠΈΡΠ΅ ΡΡΡΠ°Π½ΠΈΡΡ
ΠΡΠ»ΠΈ Π²ΠΎΠ·Π½ΠΈΠΊΠ°ΡΡ ΠΏΡΠΎΠ±Π»Π΅ΠΌΡ ΡΠΎ ΡΠΊΠ°ΡΠΈΠ²Π°Π½ΠΈΠ΅ΠΌ Π²ΠΈΠ΄Π΅ΠΎ, ΠΏΠΎΠΆΠ°Π»ΡΠΉΡΡΠ° Π½Π°ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ ΠΏΠΎ Π°Π΄ΡΠ΅ΡΡ Π²Π½ΠΈΠ·Ρ
ΡΡΡΠ°Π½ΠΈΡΡ.
Π‘ΠΏΠ°ΡΠΈΠ±ΠΎ Π·Π° ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΠ΅ΡΠ²ΠΈΡΠ° ClipSaver.ru
Benefit-Risk Analysis is an important concept for risk management of medical devices, though it is difficult and challenging to do in practice. This is a key requirement in the EU MDR recently put into effect and is very important to understand in order to properly evaluate the safety of medical devices. In this video, we will review some of the key regulatory requirements in EU-MDR and discuss an overall framework of key factors to do a benefit-risk analysis. πSubscribe to the Let's Talk Risk! newsletter https://naveenagarwalphd.substack.com/ πConnect on LinkedIn Β Β /Β naveenagarwalΒ Β