New Manufacturing Facility Achieves ISO Certification

Key points

• New Santa Clara facility achieves ISO 13485 certification
• Supports transition to expanded manufacturing capacity
• Automated assembly machinery installation planned

Full summary

EBR Systems, Inc. announced that its new Santa Clara manufacturing facility has achieved ISO 13485 certification, a significant milestone in quality and operations. The certification, granted by the British Standards Institution, supports the company's transition to an expanded facility with increased capacity for its WiSE System. The new facility includes additional manufacturing equipment, including automated assembly machinery, which will improve manufacturing efficiency and increase production capacity by approximately 500% upon FDA approval. This expansion is crucial for EBR's commercial scale-up in the U.S. and aligns with the company's broader strategy for the U.S. commercial rollout of the WiSE System.