Recently, CH Biomedical, a technological pioneer in the global Ventricular Assist Device (VAD) field, successfully obtained ISO 13485:2016 certification from the authoritative third-party certifier BSI (Certificate No.: MD 758952). This achievement confirms that the company has achieved internationally standardized excellence across the design, development, manufacturing, and post-marketing quality management of its VAD products.
ISO 13485:2016 — Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes — was developed by the International Organization for Standardization (ISO) and is widely recognized as the premier global model in the industry. It also serves as the foundation for CE certification under EU medical device directives and regulations. Notably, in February of this year, the FDA proposed amendments to its Quality System Regulation (21 CFR 820) to align QSR 820 requirements with ISO 13485:2016. Accordingly, acquiring ISO 13485 certification lays a solid foundation for further entry into mainstream international markets and accelerates the company's expansion into Europe and the United States.
A Ventricular Assist Device (VAD) is an implantable medical device with high technological barriers, integrating cutting-edge innovations in mechanical engineering, electronics, software control, fluid dynamics, and biomedical engineering, along with advanced international expertise in device development and manufacturing. From the outset, CH Biomedical built its quality management system with patient safety as the top priority, ensuring stable and reliable product quality designed with the characteristics of Class III implantable, active, and sterile devices. To achieve this, the company broke its quality system processes into nearly 30 distinct elements, each governed by comprehensive procedures and standards. Throughout the product lifecycle, quality control is continually reinforced through internal audits, management reviews, and corrective and preventive actions. During the certification process, CH Biomedical’s entire quality management system throughout the life cycle of medical devices, from design and development, supplier management, and production, to storage, distribution, installation, and after-sales service, successfully passed a rigorous and comprehensive professional audit covering the entire lifecycle of its medical devices.
As a high-tech medical enterprise, CH Biomedical firmly believes that a robust and compliant quality management system is the cornerstone of product quality and reliability. The company’s quality management system integrates regulatory requirements from China’s Good Manufacturing Practice for medical devices, ISO 13485, and the U.S. FDA Quality System Regulation to meet the demands of diverse global markets. Looking ahead, CH Biomedical will remain committed to continuous, customer-centric improvement, upholding an ethos of excellence to further optimize its existing quality management system. By doing so, it aims to spearhead advancements in global VAD technology and help more heart failure patients, as well as their families, rediscover healthy, fulfilling lives.
