{"id":3073,"date":"2026-06-23T03:07:42","date_gmt":"2026-06-22T19:07:42","guid":{"rendered":"https:\/\/chinabatterymanufacturer.com\/"},"modified":"2026-06-23T03:12:37","modified_gmt":"2026-06-22T19:12:37","slug":"iso-13485","status":"publish","type":"page","link":"https:\/\/chinabatterymanufacturer.com\/ja\/certifications\/iso-13485\/","title":{"rendered":"ISO 13485 Certification"},"content":{"rendered":"
\n\t\t\t\t
\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

ISO 13485 Certification<\/h1>\n\t\t\n<\/div>\n
\n \t\t\t

Medical Device Quality Management System Standard<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n
\n \t\t\t

Standard Name<\/p>\n\t\t\t\t\t

Medical Devices - Quality Management Systems<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Issued By<\/p>\n\t\t\t\t\t

International Organization for Standardization (ISO)<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Current Version<\/p>\n\t\t\t\t\t

ISO 13485:2016 (with 2018 amendments)<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

\n \t\t\t

What is ISO 13485?<\/h2>\n\t\t
\n \t\t\t

ISO 13485 is the international standard that specifies requirements for a quality management system for organizations that design, manufacture, and distribute medical devices. It ensures that medical devices are designed, manufactured, and maintained to the highest quality and safety standards.<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

This certification is mandatory for companies selling medical devices in regulated markets and demonstrates a commitment to patient safety and product quality.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n \t\t\t

Key Requirements<\/h2>\n\t\t\n<\/div>\n
\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t
\n \t\t\t

Quality Management System<\/p>\n\t\t\t\t\t

Establish and maintain a comprehensive QMS documentation<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t
\n \t\t\t

Risk Management<\/p>\n\t\t\t\t\t

Implement systematic risk identification and mitigation procedures<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t
\n \t\t\t

Design Control<\/p>\n\t\t\t\t\t

Control design development, verification, and validation processes<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t
\n \t\t\t

Production Control<\/p>\n\t\t\t\t\t

Ensure consistent manufacturing and process controls<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t
\n \t\t\t

Post-Market Surveillance<\/p>\n\t\t\t\t\t

Monitor device performance after market release<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t
\n \t\t\t

Complaint Handling<\/p>\n\t\t\t\t\t

Establish procedures for handling customer complaints and recalls<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n \t\t\t

Applicability for Medical Batteries<\/h2>\n\t\t\n<\/div>\n
\n
\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

Applicable Products<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

\u2022 Implantable medical device batteries<\/p>\n\t\t\t\t\t

\u2022 Pacemaker batteries<\/p>\n\t\t\t\t\t

\u2022 Diagnostic equipment batteries<\/p>\n\t\t\t\t\t

\u2022 Patient monitor batteries<\/p>\n\t\t\t\t\t

\u2022 Surgical instrument batteries<\/p>\n\t\t\t\t\t

\u2022 Wearable medical device batteries<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

\n
\n \t\t\t

Benefits for JHY Customers<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

\u2713 Market access in regulated regions<\/p>\n\t\t\t\t\t

\u2713 Enhanced product credibility<\/p>\n\t\t\t\t\t

\u2713 Reduced liability risks<\/p>\n\t\t\t\t\t

\u2713 Improved customer confidence<\/p>\n\t\t\t\t\t

\u2713 Compliance with regulations<\/p>\n\t\t\t\t\t

\u2713 Demonstrated quality commitment<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n \t\t\t

Why Choose JHY for ISO 13485 Certified Batteries<\/h2>\n\t\t\n<\/div>\n
\n
\n \t\t\t

Full ISO 13485 Compliance<\/p>\n\t\t\t\t\t

All medical device batteries fully certified and compliant<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Proven Track Record<\/p>\n\t\t\t\t\t

2000+ patents and 50+ PhD engineers in R&D<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Global Manufacturing<\/p>\n\t\t\t\t\t

7 manufacturing facilities across Asia and beyond<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Rapid Certification<\/p>\n\t\t\t\t\t

Streamlined processes for faster time-to-market<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Quality Assurance<\/p>\n\t\t\t\t\t

0.03% defect rate and 3000+ cycle life guarantee<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30b5\u30dd\u30fc\u30c8<\/p>\n\t\t\t\t\t

Dedicated technical team for medical device applications<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n \t\t\t

Implementation Timeline<\/h2>\n\t\t\n<\/div>\n
\n
\n \t\t\t1<\/span>\n\t\t
\n \t\t\t

Phase 1: Gap analysis and planning<\/p>\n\t\t\t\t\t

1-2 months<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

\n \t\t\t2<\/span>\n\t\t
\n \t\t\t

Phase 2: Documentation development<\/p>\n\t\t\t\t\t

2-3 months<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

\n \t\t\t3<\/span>\n\t\t
\n \t\t\t

Phase 3: System implementation<\/p>\n\t\t\t\t\t

2-3 months<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

\n \t\t\t4<\/span>\n\t\t
\n \t\t\t

Phase 4: Internal audit and correction<\/p>\n\t\t\t\t\t

1-2 months<\/p>\n\t\t\n<\/div>\n\n<\/div>\n

\n \t\t\t5<\/span>\n\t\t
\n \t\t\t

Phase 5: Third-party certification audit<\/p>\n\t\t\t\t\t

1 month<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n \t\t\t

\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\t\t\n<\/div>\n
\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

Is ISO 13485 mandatory for medical device batteries?<\/p>\n\t\t\n<\/div>\n\t\t\t

Yes, ISO 13485 is mandatory for medical device manufacturers selling in regulated markets such as the EU, US, and many other countries.<\/p>\n\t\t\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

How long does ISO 13485 certification take?<\/p>\n\t\t\n<\/div>\n\t\t\t

Typically 6-12 months depending on the complexity of your operations and the readiness of your existing systems.<\/p>\n\t\t\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

What is the cost of ISO 13485 certification?<\/p>\n\t\t\n<\/div>\n\t\t\t

Costs vary based on company size and complexity, typically ranging from $10,000 to $50,000 for initial certification.<\/p>\n\t\t\n<\/div>\n

\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

How often must ISO 13485 be renewed?<\/p>\n\t\t\n<\/div>\n\t\t\t

ISO 13485 certification is valid for 3 years, with surveillance audits typically conducted annually.<\/p>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n

\n
\n
\n \t\t\t

Related Certifications<\/h3>\n\t\t
\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

ISO 9001<\/p>\n\t\t\n<\/div>\n\t\t\t

Quality management system certification<\/p>\n\t\t

\n \t\t\t\n\t\t\u8a73\u7d30\u306f\u3053\u3061\u3089\n\t<\/a>\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\n<\/div>\n\n<\/div>\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

ISO 14001<\/p>\n\t\t\n<\/div>\n\t\t\t

Environmental management certification<\/p>\n\t\t

\n \t\t\t\n\t\t\u8a73\u7d30\u306f\u3053\u3061\u3089\n\t<\/a>\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\n<\/div>\n\n<\/div>\n
\n
\n \t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t

ISO 10993<\/p>\n\t\t\n<\/div>\n\t\t\t

Biocompatibility evaluation<\/p>\n\t\t

\n \t\t\t\n\t\t\u8a73\u7d30\u306f\u3053\u3061\u3089\n\t<\/a>\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
\n\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n
\n
\n
\n \t\t\t

ISO 13485 Certified Products<\/h2>\n\t\t
\n
\n
\n \t\t\t

ISO 13485 Certified<\/p>\n\t\t\t\t\t

\u8d85\u8584\u578b\u96fb\u6c60<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Medical-grade ultra-thin batteries<\/p>\n\t\t\n<\/div>\n

\n \t\t\t\n\t\t\u8a73\u7d30\u3092\u898b\u308b\n\t<\/a>\t\t\n<\/div>\n\n<\/div>\n
\n
\n \t\t\t

ISO 13485 Certified<\/p>\n\t\t\t\t\t

\u9ad8\u5206\u5b50\u30bb\u30eb<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Medical-grade polymer cells<\/p>\n\t\t\n<\/div>\n

\n \t\t\t\n\t\t\u8a73\u7d30\u3092\u898b\u308b\n\t<\/a>\t\t\n<\/div>\n\n<\/div>\n
\n
\n \t\t\t

ISO 13485 Certified<\/p>\n\t\t\t\t\t

\u6210\u5f62\u30fb\u7279\u6ce8\u30d5\u30a9\u30fc\u30e0<\/p>\n\t\t\n<\/div>\n

\n \t\t\t

Medical-grade custom batteries<\/p>\n\t\t\n<\/div>\n

\n \t\t\t\n\t\t\u8a73\u7d30\u3092\u898b\u308b\n\t<\/a>\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n
\n
\n
\n \t\t\t

Ready to Achieve ISO 13485 Certification?<\/h2>\n\t\t
\n \t\t\t

Our ISO 13485 certified medical device batteries meet the highest quality and safety standards. Contact our team to discuss your medical device battery requirements.<\/p>\n\t\t\n<\/div>\n\t\t\t\n\t\tRequest Medical Battery Consultation\n\t<\/a>\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"

ISO 13485 Certification Medical Device Quality Management System Standard Standard Name Medical Devices – Quality Management Systems Issued By International Organization for Standardization (ISO) Current Version ISO 13485:2016 (with 2018 amendments) What is ISO 13485? ISO 13485 is the international standard that specifies requirements for a quality management system for organizations that design, manufacture, and distribute medical devices. It ensures that medical devices are designed, manufactured, and maintained to the highest quality and safety standards. This certification is mandatory for companies selling medical devices in regulated markets and demonstrates a commitment to patient safety and product quality. Key Requirements Quality Management System Establish and maintain a comprehensive QMS documentation Risk…<\/p>","protected":false},"author":1,"featured_media":0,"parent":2718,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_kad_post_transparent":"default","_kad_post_title":"hide","_kad_post_layout":"fullwidth","_kad_post_sidebar_id":"","_kad_post_content_style":"unboxed","_kad_post_vertical_padding":"hide","_kad_post_feature":"hide","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"class_list":["post-3073","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/pages\/3073","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/comments?post=3073"}],"version-history":[{"count":3,"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/pages\/3073\/revisions"}],"predecessor-version":[{"id":3079,"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/pages\/3073\/revisions\/3079"}],"up":[{"embeddable":true,"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/pages\/2718"}],"wp:attachment":[{"href":"https:\/\/chinabatterymanufacturer.com\/ja\/wp-json\/wp\/v2\/media?parent=3073"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}