Shanghai Wonzigene Biological obtained ISO13485 certification
In September 2023, Shanghai Wonzigene Biotechnology Co., Ltd. passed the strict audit of SGS experts and successfully obtained the ISO13485:2016 “Medical Device Quality Management System” certification. This important milestone marks a significant breakthrough in our development process!
This certification further demonstrates our outstanding performance in quality management, as well as the safety and efficacy of the in vitro diagnostic products we provide to reassure our customers and stakeholders.
ISO13485
ISO13485 Certification Background
ISO13485 certification is one of the key certifications in the medical device industry. Its full name is “Medical device quality management System for regulatory requirements”, especially designed for the field of medical devices. The certification standard requires the organization to establish, implement and maintain a medical device quality management system to ensure that the safety and quality of products meet regulations and customer needs, marking the organization has reached the international level in quality management, and maintain competitiveness with the international market.
The standard is based on ISO9001 to increase the special requirements of the medical device industry, and put forward more stringent control requirements for product identification, process control and other aspects. Compared with ISO9001 standard applicable to all types of organizations, ISO13485 is more professional, focusing on the design and development of medical devices, production, storage and circulation, installation, service and final decommissioning and disposal of related industries.
For enterprises that obtain ISO13485 certification, it means that they have the ability to meet customer needs, comply with regulatory requirements and continuous improvement, so as to enhance the trust of users and regulators in enterprise products and services.
Importance of ISO13485 certification
1, The pursuit of excellent quality management: ISO13485 standard encourages enterprises to establish a set of strict quality management process to ensure that the design, production and service process of medical devices conforms to regulations and relevant standards.
2, Improve market competitiveness: holding ISO13485 certification enterprises can show the reliability and effectiveness of their quality management system in the market, so as to enhance their own competitiveness, and attract more customers and partners.
Compliance with regulatory requirements: ISO13485 certification requires enterprises to comply with local and international medical device quality standards and regulatory requirements, so that enterprises can better deal with the compliance inspection of regulatory agencies.
In general, ISO13485 certification is very important for medical device manufacturers, it can not only improve product quality, but also provide customers with reassurance and safety assurance. With this certification, companies will be more confident in facing regulatory scrutiny and demonstrate their strong commitment and responsibility to comply with regulations. This not only helps to maintain the reputation of the enterprise, but also brings more business opportunities and market share for the enterprise.
Wonzigene and ISO13485 certification
As a manufacturer focused on in vitro diagnostic reagents, Wonzigene has been committed to continuously improving product quality and customer service since its establishment in 2021, and strives to pursue excellent quality and customer satisfaction. In order to further demonstrate our commitment to quality, we applied for the “Medical Device Quality Management System Certification” and successfully obtained the certificate. The acquisition of ISO13485 certification shows that our quality management system meets the relevant requirements. We will continue to work hard to provide higher quality diagnostic products to meet the needs of customers and make an important contribution to the development of the industry. At the same time, we will continue to follow the quality management system requirements, constantly improve product quality and production process, and provide customers with better products.
Finally, Shanghai Wonzigene Biotechnology Co., Ltd. would like to thank all partners for their support and trust. We look forward to working with you to create a better future!
