Jeet Medical Successfully Passing the ISO13485 Certification for Medical Devices
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- Issue Time
- Nov 8,2022
Summary
Achieving ISO13485 certification is a significant milestone in Jeet Medical's development journey, marking a critical step towards high-quality and high-standard growth.
The successful attainment of ISO13485 certification for our medical device quality management system underscores Jeet Medical's capability to consistently produce and deliver high-quality products and services that meet both customer and regulatory requirements.
This achievement demonstrates that our processes in product design, development, manufacturing, and sales adhere to international standards. Jeet Medical rigorously implements the ISO 13485:2016 requirements, utilizing systematic, scientific, and standardized management to continuously enhance our management practices and ensure product quality. This, in turn, strengthens our product competitiveness and increases our market share.
Achieving ISO13485 certification is a significant milestone in Jeet Medical's development journey, marking a critical step towards high-quality and high-standard growth. Moving forward, Jeet Medical will continue to delve deeply into the medical device field, striving to contribute significantly to China’s healthcare industry as the sector evolves.
About ISO13485 certification
ISO 13485 is the quality management system standard for the medical device industry.
Compared to ISO9001, ISO 13485 places greater emphasis on regulatory requirements, incorporating many industry-specific regulations and detailed requirements. It is the most authoritative international quality system standard for the medical device industry.
The standard's requirements cover every phase of the medical device life cycle, including project initiation, design and development, sample preparation, registration testing, clinical evaluation, product registration, manufacturing, storage, installation or servicing, use, post-market surveillance feedback, and disposal.