ISO certification "ISO 13485 (Medical devices - In vitro diagnostic medical devices)"
A management system standard for responding to regulations on products and services in the medical device industry and reducing risks!
"ISO 13485" is an international standard for quality management systems specifically tailored for the medical device industry. It applies to organizations involved in the lifecycle of medical devices and in vitro diagnostic products. It is adopted as a basis for quality management methods in regulations concerning medical devices in countries around the world, including Japan. [Overview] ■ Target Organizations - Organizations involved in the lifecycle of medical devices and in vitro diagnostic products (design and development, manufacturing, storage, distribution, installation, ancillary services, etc.) ■ Purpose of the Standard - To consistently provide products and services that meet customer requirements and regulatory requirements in medical devices. *For more details, please refer to the PDF document or feel free to contact us.
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basic information
**Effects of Certification Acquisition** - Improvement of operational efficiency and strengthening of organizational structure - Promotion of legal compliance - Smooth succession of operations through visualization of work - Management of KPIs (Key Performance Indicators) - Risk management - Enhancement of corporate value through continuous improvement - Achievement of transaction requirements including foreign companies - Improvement of social trust and customer satisfaction through quality assurance *For more details, please refer to the PDF document or feel free to contact us.*
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Applications/Examples of results
【Examples of Target Products】 ■ Medical devices and in vitro diagnostic drugs specified by Japan's Pharmaceuticals and Medical Devices Act (PMDA) (including implantable medical devices) ■ Medical devices and in vitro diagnostic drugs specified by other countries (including implantable medical devices) ■ Parts, materials, and substances incorporated into the above products *For more details, please refer to the PDF document or feel free to contact us.
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The organization conducts testing, inspection, and certification of management systems, products, and the environment as a fair and neutral third-party institution, providing safety, security, and trust to customers and consumers. It is the foundation of the economy, and our mission is to continue to reliably implement this service. To continue to be of service to our customers, we believe it is important to accumulate knowledge and technology to respond to needs, develop services based on this, and provide services that are globally accepted. As a frontliner of a fair and neutral third-party organization, we offer total solutions that support the development and trust of our customers with world-class services.