Post by CorWave

We are thrilled to announce that CorWave has secured ISO 13485 certification across its entire operations.   ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. Covering the design, development, manufacturing, distribution and servicing of implantable LVADs, the certification demonstrates CorWave’s ability to master the entire value chain as we approach our pivotal trial and future commercial deployment.   Implantable ventricular assist devices are among the most complex medical technologies in the world. By achieving this certification, we demonstrate our ability to:   ➡ Build and operate the infrastructure of operational excellence required to develop, manufacture and distribute these devices in-house ➡ Ensure rigorous risk management, strict traceability and the highest standards of patient safety ➡ Uphold our patient-centric approach and commitment to serving medical teams and advanced heart failure patients at the highest level   A huge thank you to all the CorWavers whose hard work, expertise and dedication made this milestone possible.   Together, we are one step closer to our mission: save heart failure patients and offer them an active life.