Wuhan Life Origin Biotech has recently successfully obtained the on-site certification audit of EN ISO13485:2016 by TÜV SÜD and has received the certificate. This is a powerful help for Wuhan Life Origin Biotech to create a global diagnostic testing service!
Rheinland ISO13485 certification is a quality management system standard for the medical device industry. It provides professional guidance and requirements regarding management responsibilities, resource management, product realization, measurement, analysis, and improvement, etc. It ensures that medical devices are designed for their intended use, development, production, installation and delivery are all continuously safe and effective.
The significance of ISO13485 certification:
1. Improve the management level of the enterprise, avoid legal risks, and increase the visibility of the enterprise.
2. Improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits.
3. ISO13485 certification is conducive to eliminating trade barriers and obtaining a passport to enter the international market.
4. It is beneficial to enhance the competitiveness of products and increase the market share of products.
5. Effectively reduce the risk of product quality accidents or adverse events through effective risk management.
6. Improve employees' sense of responsibility, motivation, and dedication.
Post time: Jun-14-2023