FDA 483 - Hamilton Medical AG - July 19, 2022

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.