We are proud to announce that we have received EN ISO 13485:2016 certification from EU Notified Body DQS Medizinprodukte GmbH!

This certification reflects months of hard work and is another key approval of our Quality Management System. A special thank you to our Quality Manager Christian Morales who has commented on this success;

“This achievement reflects our constant commitment to maintaining the highest quality standards expected by regulators, customers and patients.”

This achievement moves us closer to achieving CE Mark certification for our Chitogel Endoscopic Sinus Surgery Kit.

Who is DQS Medizinprodukte GmbH?

As an independent and competent management partner for companies of all sizes and in all sectors, DQS Medizinprodukte GmbH offers objective assessments according to recognized standards and specialist or industry-specific regulations. The company, based in Frankfurt am Main, as part of the global DQS Group, is the only major certifier to focus on the assessment and certification of management systems in companies and organizations.

What is the EN ISO 13485:2016 certificate?

The ISO 13485:2016 certificate acknowledges that we have met the specific ISO 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 and applicable regulatory requirements.