Quality Systems


Quality Objective

Coherex Medical is committed to maintaining the effectiveness of our quality management system to benefit patients, doctors, employees, and other stakeholders associated with its products.

Quality Certification

Coherex has maintained certification to ISO 13485:2003, the international quality management system standard for medical device manufacturers since January 2007 and was recertified in 2014.

Coherex has earned both the EC Design Examination Certificate and the EC-Certificate for its Coherex WaveCrest® LAA Occlusion System.

Quality Inspection

Coherex’s Quality Laboratory utilizes state-of-the-art equipment to inspect components and finished products. Skilled and experienced technicians are dedicated to ensuring that medical devices comply with exacting specifications.


Structural Heart Solutions

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