Medical DeviceNews

Nureca’s subsidiary receives ISO 13485 certification for Indian medical device facility

The certification was received for nebulisers and blood pressure monitors

Nureca Technologies, a wholly-owned subsidiary of Nureca, has obtained ISO 13485:2016 certification from notified body Intertek, for nebulisers and blood pressure monitors.

Saurabh Goyal, MD, Nureca stated, “We are excited to receive this certification, which represents another key milestone for our globally certified Made in India medical devices manufacturing site. It will open new avenues for our flagship brand “Dr Trust”, enabling us to export these devices to many more countries. This certification solidifies our commitment to quality and compliance in the world of health. I am proud of our team who made this possible.”

ISO 13485 was written to support medical device manufacturers in a quality management system (QMS) that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery through to the disposal of medical devices that are safe for their intended purpose.

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