ISO 13485 Certification

ISO 13485 CertificationCool Pair Plus has received ISO 13485 Certification from accredited certification body Orion Registrar, Inc.

This certification demonstrates Cool Pair Plus’s commitment to establishing and following policies, practices and procedures to meet the customer, safety and regulatory requirements applicable to medical devices.

ISO 13485 is an International Organization for Standardization (ISO) standard that describes the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

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