483
Hamilton Medical AGHamilton Medical AG – FDA 483, Jul 19, 2022
Record Details
Hamilton Medical AG, a device specification developer in Bonaduz, Switzerland, received a Form FDA 483 for deficiencies in design validation. The inspection revealed that design validation did not adequately ensure devices conform to defined user needs and intended uses, specifically concerning cleaning and sterilization processes for ventilator components and documentation for battery life. This indicates issues with the firm's design control and validation practices for medical devices.
View Company Profile
ID · 5e1a385f-65a7-4c7f-8842-63ded2116bc1
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.