Quality & Regulatory

Excellence Through Quality

At Quasar Medical, we are dedicated to upholding the highest standards of quality. As an ISO 13485:2016 certified and cGMP compliant manufacturer, we ensure our products meet the strictest quality and IP protection controls, providing our customers with reliable and high-performance medical devices. Our innovative manufacturing processes and technologies, developed in collaboration with our medical device customers, continue to improve patient outcomes and drive industry advancements.

Regulatory & Compliance

Quality and regulatory certifications are critical for Quasar to produce high-quality, reliable products. These certifications, such as ISO 13485, and FDA registration are key to our mission of delivering safe, reliable, and quality products to our customers.

ISO 13485 Certification (BSI)

FDA Registered Facilities

  • Dongguan, China
  • Chonburi, Thailand
  • Singapore

    TFDA, Thailand

    • Chonburi, Thailand

    Health Science Authority

    • Singapore
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    Quality Policy

    At Quasar, we put quality first in everything we do. We continually improve our quality systems to provide high quality products and services that meet the requirements of customers and regulatory agencies around the world.

    Our People, Our Strength

    What sets us apart in the industry is our rigorous training program. Our production technicians undergo several months of training and testing before they are allowed to work on the production floor. Employees are continuously trained to maintain strict quality control measures throughout the production process, ensuring that every product meets our high standards of excellence. 

    Customers benefit from the high level of expertise and commitment to quality that our employees possess, enabling us to produce products of exceptional quality on a mass scale. Our commitment to quality is reflected in our customers’ satisfaction, who trust our devices consistently meet their expectations.

    High Quality, Mass Production

    The team at Quasar is committed to delivering the highest quality products to our customers. Our four production facilities, featuring over 660,000 sqft of production space and state-of-the-art class 7 and 8 clean rooms, are equipped to meet the strictest quality standards. 

    Our highly skilled team of over 2,700 production technicians enable us to rapidly ramp up and deliver mass production without compromising quality. By prioritizing quality across all aspects of our operations, we are able to consistently deliver exceptional devices that meet and exceed our customers’ expectations.

    • 660k ft² Production
    • 165k ft² Cleanrooms
    • 2,700+ Production Staff

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