Burning Rock Dx Certified by the Certification of ISO 13485 Quality Management System

Var Date:2019-08-23

Medical device industry is booming around the world, characterized by ever-updated and diversified techniques and products, an increasingly long and complicated supply chain. In such context, global regulators are increasingly demanding on whether medical devices are safe and effective. The ISO 13485 Quality Management System is a good means of assessment on whether firms have capabilities of accommodating the ever-changing global environment, building quality management systems geared to international standards, making effective risk management throughout the entire product life cycle, etc.

Lately Burning Rock Dx successfully passed certification of the ISO 13485 Quality Management System and received the corresponding certificate for Burning Rock's entire process of in vitro diagnostic (IVD) reagent and software development, production and sales, indicating that Burning Rock’s products meet international standards and are accepted by the International Standardization Organization (ISO).

The basis for the ISO 13485 Quality Management System is ISO13485:2016 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes (hereinafter referred to as the Requirements). It introduces and highlights a mass of best practices in medical device industry and accommodates requirements in Chinese NMPA Code of Quality Management on Medical Device Production, American FDA QSR 820, Japanese J-Pal Regulation 169, EU MDR& IVDR and other regulations on medical devices enacted by Brazil, Canada, Australia, etc., which is the world’s most universal standard intended for the medical device industry in particular.

Inspired by the international honor, Burning Rock Dx will continue to tighten corporate quality control by meeting the highest requirements in the industry to provide testing platforms and NGS products in compliance with international requirements for hospitals and cancer patients in China. Besides, Burning Rock Dx will also contribute to promoting sound progress of China’s cancer-targeted NGS testing undertakings based on standardization.