ISO 13485 Certification for Medical Devices Quality Management

March 23, 2018

By providing consistent design, development, production, and delivery of medical devices and their subcomponents, we achieved the ISO 13485 Certification for our quality management systems. This certification support medical device manufacturers and subcontractors in developing a quality management system that establishes and maintains the effectiveness of their processes. ISO 13485 implementation can help companies involved in any aspect of a medical device lifecycle by: Demonstrating regulatory compliance; Use of a QMS that establishes practices that yield safe and effective medical devices: Manages risk throughout the supply chain and internally to the organization: Drives process improvement.

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