驗證範圍為「步態評估用醫療器材軟體，包含設計開發、銷售以及售後服務」，以國際品質標準服務醫院、經銷商與合作夥伴

台北，2026年10月22日 — 臺灣智慧復健科技公司龍骨王股份有限公司（LongGood MediTech Ltd.）今日宣布，已通過 ARES International Certification Co., Ltd. 稽核，取得 ISO 13485:2016 醫療器材品質管理系統認證，證書編號 ARES/TW/I2609032M，驗證範圍為「步態評估用醫療器材軟體，包含設計開發、銷售以及售後服務」。

ISO 13485 是國際通行的醫療器材品質管理系統標準，要求組織在設計開發、風險管理、文件與紀錄管控、供應商管理、銷售及售後服務（包含客訴處理與矯正預防措施）等環節，建立可稽核、可追溯的管理制度。

認證資訊

• 標準：ISO 13485:2016
• 驗證機構：ARES International Certification Co., Ltd.（證書標示 IAS 認可，ACC NO. MSCB-171，並標示 IAF MLA 標誌）
• 證書編號：ARES/TW/I2609032M
• 簽發日期：2026-09-15
• 有效日期：2029-09-14（須按期通過監督稽核以維持有效）
• 驗證範圍（依證書原文）：步態評估用醫療器材軟體，包含設計開發、銷售以及售後服務。

本次認證適用範圍以證書所載為準。ISO 13485 認證的是組織的品質管理系統，並非個別產品的上市許可；各國醫療器材上市仍須依當地主管機關規定另行辦理。

對醫院、經銷商與合作夥伴的意義

對醫院與臨床單位而言，驗證範圍內的步態評估軟體，其設計開發、變更管理、售後服務與問題回報，均在經第三方稽核的品質系統下運作，有助於採購評估及資訊與品質審查。對經銷商與海外合作夥伴而言，ISO 13485 是許多市場醫療器材註冊程序中常見的要求或重要參考（例如臺灣 TFDA、新加坡 HSA），可作為日後在各市場申請註冊的基礎；實際要求與時程依各地法規而定。

品質承諾與長期願景

取得 ISO 13485 認證，代表龍骨王將「品質」落實為全公司的日常文化：從需求定義、設計開發與驗證，到銷售、售後服務及上市後回饋，每一個環節都依循嚴謹、可追溯的流程運作，並以病人安全為核心考量。這不僅是一張證書，更是我們對醫院、臨床人員、經銷商與合作夥伴的承諾——讓每一位使用者都能安心信賴龍骨王的技術與服務。

這項認證也是龍骨王邁向下一階段的重要基石。以經第三方稽核的品質管理系統為基礎，龍骨王將持續深耕臺灣市場，並與東南亞等海外地區的合作夥伴及經銷商攜手，逐步推進各市場所需的法規與導入作業。我們的長期願景，是讓精準、量化的步態評估與智慧復健科技走進更多醫院、長照機構與家庭，協助更多人安全行動、重拾生活品質。

關於龍骨王

龍骨王股份有限公司（LongGood MediTech Ltd.）為臺灣智慧復健科技公司，致力以體感互動、步態分析、AI 影像與遠距復健技術，協助醫院、長照機構與居家場域提升復健與跌倒預防的品質與可及性。

媒體與業務聯絡

龍骨王業務團隊 LongGood Sales Team
Email：sales@longgood.com.tw
LINE 官方帳號：@longgood

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English Version: LongGood Achieves ISO 13485:2016 Certification for Its Medical Device Quality Management System

Certified scope: medical device software for gait assessment, including design and development, sales, and post-market services

Taipei, October 22, 2026 — LongGood MediTech Ltd. (龍骨王股份有限公司), a Taiwanese rehabilitation technology company, today announced that it has been certified to ISO 13485:2016 by ARES International Certification Co., Ltd. under certificate No. ARES/TW/I2609032M. The certified scope is “Medical device software for gait assessment, including design and development, sales, and post-market services."

ISO 13485 is the international quality management system standard for the medical device sector. It requires documented, auditable and traceable processes across design and development, risk management, document and record control, supplier control, sales and post-market activities, including complaint handling and corrective and preventive action.

Certificate details

• Standard: ISO 13485:2016
• Certification body: ARES International Certification Co., Ltd. (the certificate carries the IAS accreditation mark, ACC NO. MSCB-171, and the IAF MLA mark)
• Certificate No.: ARES/TW/I2609032M
• Issue date: 2026-09-15
• Registration expiration: 2029-09-14 (subject to successful surveillance audits)
• Scope (as stated on the certificate): Medical device software for gait assessment, including design and development, sales, and post-market services.

The certificate applies only to the scope stated on it. ISO 13485 certifies an organisation’s quality management system. It is not a product approval or marketing authorisation, and each market’s regulatory registration remains a separate process.

What it means for hospitals, distributors and partners

For hospitals and clinics, design, change control, service and issue reporting for the in-scope gait assessment software run under a third-party-audited quality system, which supports procurement, IT and quality reviews. For distributors and international partners, ISO 13485 is commonly required or referenced in medical device registration processes (for example with Taiwan’s TFDA or Singapore’s HSA) and gives a foundation for future registrations. Actual requirements and timelines depend on each market.

A commitment to quality and a long-term vision

ISO 13485 certification reflects how LongGood makes quality part of its everyday culture. Our processes run from requirements and design to verification, sales, service and post-market feedback, and each step is rigorous and traceable. Patient safety is central to all of them. The certificate is a commitment to hospitals, clinicians, distributors and partners that they can rely on LongGood’s technology and service.

The certification is also a foundation for LongGood’s next stage. Building on a quality management system that has passed third-party audits, LongGood will continue to grow in Taiwan. We will also work with partners and distributors in Southeast Asia and other markets as we take on the regulatory and implementation work each market requires. Our long-term vision is to bring precise, measurable gait assessment and smart rehabilitation technology to more hospitals, long-term care facilities and homes, so that more people can move safely and regain their quality of life.

About LongGood

LongGood MediTech Ltd. is a Taiwanese rehabilitation technology company. It uses motion sensing, gait analysis, AI video and tele-rehabilitation technologies to help hospitals, long-term care facilities and home settings improve the quality of rehabilitation and fall prevention and make it easier to access.

Media and sales contact

LongGood Sales Team
Email: sales@longgood.com.tw
LINE Official Account: @longgood