Icon Energy obtained "ISO13485:2016 Medical Device Quality Management System" certificate

Icon Energy obtained "ISO13485:2016 Medical Device Quality Management System" certificate

On October 27th, 2020, Icon Energy System (Shenzhen) Co., Ltd. Obtained "ISO13485:2016 Medical Device Quality Management System" certificate issued by the SGS Certification Authority. The scope of the certificate is used for the design and manufacture of lithium batteries for medical products (non-implantable and non-radiative). The ISO13485 is a quality management system standard applicable to the regulatory environment of medical devices, which has a full name of "Medical Device Quality Management System Regulatory Requirements". ISO13485 focuses on the organizations related to medical device’s design and development, production, storage and circulation, installation, service, and final decommissioning and disposal. It is a highly professional system certification.

As a key component of medical equipment, battery products are used as the main or backup power supply to support the normal operation of medical equipment or to ensure the smooth switching of equipment between different power sources. The successful certification of ISO13485:2016 is a high recognition of Icon Energy's product quality, risk-based method management and application to the quality management system process. It also represents that Icon Energy can provide high-quality power solutions for customers of medical devices, which can meet the requirements of the Medical device Quality Management System and reach the corresponding international standards.

Icon Energy obtained "ISO13485:2016 Medical Device Quality Management System" certificate.

Icon Energy System (Shenzhen) Co., Ltd. as one of the subsidiaries of Highpower Group, was established in 2011. It is a national high-tech enterprise based on the R&D, design and manufacture of power systems for Ni-MH batteries and lithium-ion batteries. It also provides clean energy solutions centered on energy storage.

The company's products are widely used in consumer electronics, smart homes, handheld devices, vacuum cleaners, portable medical equipment, garden tools, light electric vehicles, household energy storage and other applications.

The company has strong technical strength and is equipped with complete equipment and systems dedicated to power system testing. Icon Energy, which strictly adheres to the industry's highest standards, also attaches   great importance to standardized production management and is equipped with professional and automated packing production lines at the same time. In addition to the ISO13485:2016 certification, Icon has successively passed relevant international certifications in terms of quality, safety, technology, environment, region and social responsibility, such as ISO9001:2000, ISO14001:2004, QC080000 system certification as well as CE, UL, PSE and other product certifications. Icon Energy has been recognized by the industry for its vibrant strength and excellent product quality. The company will continue to organize production management in strict accordance with the requirements of the international management system, continuously improve internal management and control, and strive to achieve faster, better, and more sustainable development!