Good News | BPI Successfully Achieves ISO13485 Medical Device Quality Management System Certification

By BPI Dec 16, 2025

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Recently, BPI successfully passed the audit by an authoritative organization and officially obtained the ISO13485 Medical Device Quality Management System certification.

This marks another important milestone in BPI’s development, signifying that our R&D, production, and quality management for medical device batteries now fully meet international standards.

ISO13485 is a globally recognized quality management standard in the medical device industry and is considered a key requirement for entering the international market.

It sets strict requirements for companies in product development, manufacturing, quality control, risk management, and after-sales service, ensuring that medical device products maintain high safety and reliability throughout their lifecycle.

In simple terms, ISO13485 is an “international passport.” Only certified companies can demonstrate their capability and qualifications to produce medical device-related products.

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Significance of the Certification

BPI's successful ISO13485 certification signifies an upgrade in our overall capabilities and service quality:

Quality Assurance: Every medical battery, from raw materials and production processes to final testing, is backed by a strict quality control system.
International Recognition: This certification is an authoritative standard in the medical device industry, demonstrating that our management system aligns with global standards.
Market Access: With the certification, BPI is qualified to develop and produce medical device batteries, creating opportunities to enter broader international medical markets.
Customer Trust: The certification strengthens customer confidence in BPI batteries, laying a solid foundation for long-term partnerships.

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Looking Ahead

Obtaining ISO13485 is just a new beginning. In the future, BPI will:

Continuously invest in R&D to create safer and more efficient medical battery solutions;
Continuously improve our quality management system to enhance product reliability and stability;
Deepen engagement in medical devices, healthcare, and emergency rescue sectors, expanding application scenarios;
Collaborate with global partners to jointly advance the development of the medical and healthcare industry.

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