EBR Systems (ASX:EBR) has secured International Organization for Standardization (ISO) 13485 certification for its new Santa Clara manufacturing facility following an assessment by the British
Standards Institution, marking a key milestone in the company's quality and operational capabilities, according to a Monday filing with the Australian bourse.
The expanded facility's automated assembly machinery is expected to increase Wireless Stimulation Endocardially system production capacity by around 500%, while improving efficiency, reducing costs, and supporting the company's US commercial expansion, the filing said.
The US Food and Drug Administration pre-approval inspection is scheduled for September, with facility approval anticipated by year-end, the filing added.
The company's shares rose 4% in recent Monday trade.