Recently, Forlinx Embedded won the ISO 13485 Medical Device Quality Management System certification, marking a milestone achievement that signifies the company's quality management system in the medical device field has fully met international standards, equipped with a comprehensive risk management mechanism.

ISO 13485 is an internationally recognized standard that outlines the requirements for a Quality Management System (QMS) specifically designed for the medical device industry. This standard covers the entire lifecycle of medical devices, from design and development to production, installation, and servicing.

Key aspects of ISO 13485 include:

Purpose and Scope

• Ensures medical devices consistently meet customer and regulatory requirements;
• Applies to organizations of all sizes involved in any stage of the medical device lifecycle;
• Covers design, production, installation, storage, development, and servicing of medical devices.

Key Requirements

• Quality Management System: Implementation and maintenance of a QMS that meets the standard's requirements;
• Risk Management: A risk-based approach to product development and realization;
• Process Validation: Ensuring processes consistently produce the intended results;
• Regulatory Compliance: Meeting statutory and regulatory requirements;
• Traceability and Recall: Effective systems for product traceability and recall.

By obtaining ISO 13485 certification, Forlinx Embedded further demonstrates its professional capabilities and commitment to high-quality standards in the medical device field. For 18 years, Forlinx Embedded has consistently emphasized both technological innovation and quality management, focusing on providing high-performance and highly reliable embedded solutions for customers. The company has won multiple international certifications including ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System. These honors not only highlight Forlinx's outstanding achievements in various aspects but also signify its wide recognition and trust in the global market.

Looking ahead, Forlinx Embedded will continue to increase R&D investment, accelerate technological innovation, and continuously enhance product quality and service levels. Additionally, it will actively respond to national policy directions and market demands, driving innovation in smart healthcare, industrial automation, intelligent transportation, power storage, and other fields, injecting momentum into the intelligent transformation of various industries. Forlinx will adopt a more open and cooperative attitude, advancing together with global partners to create a brilliant future for embedded technology.