• 22 May 2024
    NASK Unveils New and Upgraded FFP3 Nanofiber Respirator
  • 16 May 2024
    NASK Production and Manufacturing Center at AMC Achieves ISO 13485:2016 Certification

    Date: 09-05-2024

    A significant stride in enhancing quality management of medical equipment has been taken as the production and manufacturing site at AMC Advanced Manufacturing Center receives ISO 13485:2016 certification. This accomplishment underscores NASK's steadfast commitment to the highest quality standards, especially in the design and manufacturing of its pioneering nanofiber technology products.

    What is ISO 13485:2016?

    ISO 13485:2016 is an internationally recognized standard published in March 2016, setting out requirements for quality management systems where organizations must demonstrate their ability to consistently meet customer and applicable regulatory requirements in providing medical devices and related services.

    By obtaining the ISO 13485:2016 certification at our production and manufacturing center in AMC, we showcase our exceptional commitment to quality management systems for medical equipment manufacturers. Specifically designed for medical device manufacturers, this standard outlines requirements for a comprehensive quality management system, ensuring compliance with regulatory and customer requirements, safety standards, and the performance of medical devices.

    The ISO 13485:2016 certification validates NASK's stringent quality control measures and its adherence to the highest standards in maintaining the production and development of medical equipment. This certification not only enhances the company's reputation but also provides a competitive edge in the global market, ensuring recognition of NASK products for their quality and reliability.

    Why is ISO 13485:2016 Crucial for Scientific Medical Equipment Production Processes?

    Receiving the ISO 13485:2016 certification at the production facility in Tseung Kwan O AMC is not just about meeting international standards for NASK; it is about improving operational efficiency and product safety. This certification ensures that NASK can continue to deliver top-tier protection with products like its nanofiber respirators, guaranteeing safety, reliability, and quality. It supports the company's innovative mission while adhering to strict regulatory requirements, ensuring that every product launched into the market is effective, safe, and suitable for global consumers.

    Upholding Excellence, Paving the Way Forward

    The ISO 13485:2016 certification signifies a milestone for NASK in leading the industry in quality, innovation, and sustainability. As part of Profit Royal Pharmaceutical Limited, NASK is poised to continue its growth trajectory, driving the development of cutting-edge medical equipment and promoting global health and well-being. This certification not only reflects NASK's dedication to excellence but also strengthens its position as a leader in the field of medical equipment.

  • 09 Apr 2024
    Made in Hong Kong: The World's First Antibacterial Mask - NASK Nanofiber Showcases The Scientific Research Prowess
  • 01 Apr 2024
    NASK NANOFIBER patented technology has won the gold award at the HKIE (Hong Kong Institution of Engineers)
  • 15 Mar 2024
    Profit Royal x AMC Grand Opening
  • 05 Feb 2024
    2024 Chinese New Year Holiday Announcement
  • 24 Oct 2023
    FFP3 Surgical Respirator
  • 24 Oct 2023
    Halal Certificate