CorWave Achieves Major Regulatory Milestone with ISO 13485 Certification Across its Entire Operations

CLICHY, France--(BUSINESS WIRE)--CorWave, a clinical-stage medical company pioneering innovative cardiac assist devices, announces that its Quality Management System has been certified by an independent notified body in accordance with the international ISO 13485 standard. The certification covers the design, development, manufacturing, distribution, and servicing of implantable Left Ventricular Assist Devices (LVADs). This certification marks a foundational regulatory milestone on the path to