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

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

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 commercialization.

ISO 13485 is the international standard for Quality Management Systems in the medical device industry. It ensures regulatory compliance and guarantees operational excellence and traceability across all product-related processes to maintain quality and safety.

The certification was awarded following a comprehensive audit conducted by an independent notified body. It attests to CorWave’s operational and organizational maturity across the entire product lifecycle of its Left Ventricular Assist Devices: spanning from initial design and development through to manufacturing, distribution, and servicing. This demonstrates CorWave’s ability to manage the entire value chain required for the commercialization of its devices.