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Techcyte has earned ISO 13485:2016 compliance for its quality management system. 

When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of quality management systems is critical to customers, patients, users, and regulatory agencies. 

The process-based quality management system standard ISO 13485 is becoming increasingly important as a tool enabling manufacturers to audit the effectiveness of their systems. As more and more laboratories require the certification in order to do business with manufacturers, being able to demonstrate their ability to provide services that consistently meet customer and regulatory requirements is a must.

Marcus Malmberg, VP of Regulatory Affairs at Techcyte, stated, “Receiving our ISO 13485 certification is an important step in demonstrating Techcyte’s commitment to quality for our customers and the industry. It provides us with a sound framework to ensure that our products will consistently deliver and maintain the high standards of effectiveness and compliance that we expect.”

ISO 13485 compliance brings Techcyte another step closer towards submitting its products for FDA clearance.