

Regulatory
Emphasys Inhalation devices are offered with:
Active US DMF Type III
CE-Mark Class I
Class IIa. Undergoing:
-
Risk management
-
FMEA
-
Biocompatibility
-
DH Files
-
Clean room controls and bioburden
-
Device stabilities
Emphasys Inhalation devices are offered with:
Active US DMF Type III
CE-Mark Class I
Class IIa. Undergoing:
Risk management
FMEA
Biocompatibility
DH Files
Clean room controls and bioburden
Device stabilities