San Jose, CA, November 21, 2023 – SmartSurgN announces that SmartSurgN Sdn Bhd, our design and manufacturing facility in Malaysia, has received ISO 13485 certification from TÃœV SÃœD. This internationally recognized standard for medical device quality management systems underscores our commitment to quality, safety, and continuous improvement.Â
ISO 13485:2016 is a comprehensive standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet healthcare provider and regulatory requirements.
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The certification covers all aspects of SmartSurgN’s operations, including the design, development, production, and servicing of our medical devices. It stands as a testament to the hard work and dedication of our team, who continually strive to uphold our quality management system to the highest standards.Â
This accomplishment positions SmartSurgN for continued growth and success in the global medical device market. It also opens new opportunities for collaboration and innovation, enabling us to better serve our customers and improve patient outcomes worldwide.Â
