Reliable and stable products are the lifeline of a company. Since its establishment nearly 5 years ago, Epiprobe has always put quality first, providing users with high-quality and reliable cancer early screening products. On May 9, 2022, after a rigorous review by experts from BSI British Standards Institution Certification (Beijing) Co., Ltd., Epiprobe successfully passed the "ISO 13485:2016" medical device quality management system certification. The scope of application involved is the design, development, manufacturing, and distribution of gene methylation detection test kits (PCR-fluorescence method).
The significance of implementing ISO 13485 certification
This is a comprehensive certification of the entire process of product research and development, production, and sales within the company, indicating that the company's quality management system complies with the international standard of ISO 13485:2016 for medical device quality management systems. The company is capable of continuously producing and providing high-quality products that meet the needs of medical device customers, and has reached international standards in product design, development, production, and sales. This marks a further improvement in Epiprobe’s quality management level covering the entire product lifecycle and a move towards standardization, normalization, and internationalization of its quality management.
About ISO 13485 Certification System
ISO 13485:2016 is a quality management standard developed by the International Organization for Standardization (ISO) specifically for the medical device industry (including in vitro diagnostic reagents), covering processes such as the design and development, production, and distribution of medical devices. This standard is the most commonly used international quality system standard in the medical device industry and represents the best practices in quality management for the international medical device industry.
The Certification Process of Epiprobe's ISO 13485 Certification
In August 2021, the certification agency formally accepted Epiprobe's application for quality management system certification. From March 1st to 3rd, 2022, the audit team members conducted a rigorous on-site inspection and audit of the personnel, facilities and equipment configuration, and related documents and records of the company's production, quality, research and development, enterprise management, and marketing departments. After a careful and meticulous audit, the audit team experts believed that the quality management system structures of Shanghai Epiprobe Biology Co., Ltd. (Xuhui) and Shanghai Epiprobe Jinding Biology Co., Ltd. (Jinshan) were complete, the relevant documents were sufficient, and the execution of the quality manual, procedure documents, internal audits, management reviews, and other processes were good and fully compliant with the requirements of the ISO 13485 standard.
Comprehensive quality management helps Epiprobe achieve fruitful results
Since its establishment, Epiprobe has adhered to the value of "standing on products" and established an internal audit reviewer team to carry out the preparation of quality management system documents, internal audits and other practical work to ensure that products strictly comply with regulatory standards and internal documents throughout the entire lifecycle management process, gradually realizing comprehensive quality management. The company has obtained 4 Class I medical device filings (Good News! Epiprobe Biology Obtains Two Class I Medical Device Filings for Nucleic Acid Extraction Reagents!) and 3 European CE certifications for cancer gene methylation detection kits (Epiprobe's Three Cancer Gene Methylation Detection Kits Obtain European CE Certification), and has taken the lead in entering the market of cancer gene methylation diagnosis.
In the future, Epiprobe will strictly follow the requirements of ISO 13485:2016 quality management system, adhering to the quality policy of "Product-oriented, Technology-centered, and Service-oriented". The quality management team will continuously optimize the quality strategic goals, comprehensively control every link from reagent development to production process, and always strictly implement process control and risk management requirements specified in the quality system documents to ensure the safety and accuracy of products. The company will continuously improve its quality management level, ensure the quality of products and services, enhance the ability to continuously meet customer needs and expectations, and provide customers with higher-quality cancer early screening products and services.
Post time: Apr-28-2023