DEKRA德凱醫(yī)療器械

一站式服務

One-stop services for

medical devices

DEKRA德凱成立于1925年，旨在通過車輛檢驗確保道路安全。

如今DEKRA德凱的服務范圍更廣泛，是全球最大的獨立非上市

專家機構，涉及檢驗、檢測和認證領域。作為一家提供全方位服

務和解決方案的全球性服務商，我們助力企業(yè)提升安全、保障和

可持續(xù)性發(fā)展績效。2023年，DEKRA德凱營業(yè)總額達到41億歐

元，業(yè)務遍布世界5大洲60多個國家和地區(qū)，逾49,000名員工致

力于提供獨立的專家服務。DEKRA德凱連續(xù)榮獲EcoVadis鉑金

評級，位列前1%的可持續(xù)發(fā)展公司之列。

DEKRA was originally founded in 1925 to ensure road

safety through vehicle inspection. With a much wider

scope today, DEKRA is the world’s largest independent

non-listed expert organization in the testing, inspection,

and certification sector. As a global provider of comprehensive services and solutions, we help our customers

improve their safety, security, and sustainability

outcomes. In 2023, DEKRA generated revenue of EUR 4.1

billion. The company currently employs around 49,000

people who offer qualified and independent expert

services in approximately 60 countries on five continents.

With a platinum rating from EcoVadis, DEKRA is now in

the top one percent of sustainable businesses ranked.

這些服務包括：

These services range from:

工業(yè)資產

Industrial Assets

臨時雇傭

Temp Work

人員、流程和組織

People, Processes & Organizations

車輛交通

Vehicles

數(shù)字產品

Digital Products

safe, secure and sustainable world

for a

global partner

we will be the

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DEKRA德凱是您的醫(yī)療器械產品安全及合規(guī)的可靠伙伴

DEKRA is your reliable partner for the medical devices’ safety and compliance.

醫(yī)療器械行業(yè)是多學科交叉、知識及資金高度密集的前沿技術行業(yè)。由于直接關系到消費者的健康安全，各個國家和地區(qū)均對醫(yī)療器械制

定了嚴格的監(jiān)管制度，產品進入其市場需首先滿足市場準入要求。

The medical device industry is a cutting-edge technology industry with interdisciplinary, intensive-knowledge and

intensive-capital. As the safety of medical devices is related to the health of consumers, products must meet market access

requirements when entering global markets.

機遇與挑戰(zhàn)并存。在監(jiān)管制度不斷嚴格的環(huán)境下，制造商須在法規(guī)變化時，能夠迅速有效地做出應對，確保產品在上市前符合預期質量。

DEKRA德凱作為全球五大公告機構之一擁有兩個公告號：NB 0124和NB 0344。同時DEKRA德凱還具備醫(yī)療器械檢測的能力，憑借布局

全球的專家團隊和測試網絡，DEKRA德凱可為全球醫(yī)療器械制造商提供產品全方位一站式服務。

Opportunities coexist with challenges. With the increasingly strict regulatory system, manufacturers must be able to respond

quickly and effectively to ensure the products’ quality. As one of the five largest Notified Bodies in the world, DEKRA has two

NB numbers - NB 0344 and NB 0124. Besides, DEKRA also has the ability to test medical devices. With its global expert team

and testing network, DEKRA can provide a full range of one-stop services for medical device manufacturers.

我們的服務

Our Services

醫(yī)療器械認證 Medical Devices Certification

醫(yī)療器械法規(guī)認證（MDR 2017/745）

Medical Device Regulatory Certification (MDR 2017/745)

體外診斷醫(yī)療器械法規(guī)認證（IVDR 2017/746）

IVDR Medical Device Regulatory Certification (IVDR 2017/746)

CB認證

CB Certification

DEKRA Mark認證

DEKRA Mark

巴西INMETRO認證

Brazil INMETRO Certification

cDEKRAus認證

cDEKRAus Certification

英國UKCA認證

Britain UKCA Certification

ISO 13485:2016認證

ISO 13485:2016 Certification

MDSAP認證

MDSAP Certification

Technical Cooperation Program (TCP)

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解決方案 Solution

多國認證

Global Market Access

再處理（清洗、消毒、滅菌驗證）

Medical Devices Reprocessing

(Cleaning, Disinfection and Sterilization Verification)

生物兼容性

Biocompatibility (ISO 10993, ISO 18562 etc.)

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醫(yī)療器械測試與評估 Medical Devices Testing and Evaluation

電氣安全以及性能測試

Electrical Safety and Performance Testing

(IEC/EN/ISO 6(8)0601, GB 9706, IEC/EN 61010, GB 4793)

電磁兼容性測試

EMC Testing

(IEC/EN 60601-1-2, YY 9706.102, IEC 61326, GB/T 18268)

可靠性測試

Reliability Testing

老化測試

Aging Testing

電池測試

Battery Testing

無線互聯(lián)、功能安全、網絡安全

Wireless Connectivity, Functional Safety and Cyber Security

化學和材料測試（RoHS、REACH等）

Chemical and Material Testing (RoHS, REACH, etc.)

機械測試

Mechanical Testing

可用性評估

Usability Evaluation

風險評估

Risk Evaluation

軟件評估（IEC/EN 62304）

Software Evaluation (IEC/EN 62304)

環(huán)境意識設計評估

Environmentally Conscious Design Evaluation

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為什么選擇DEKRA德凱

Why DEKRA?

As the world’s leading testing and certification organization, DEKRA has developed rapidly in the field of medical testing. DEKRA

Testing Center has a professional testing team, and has obtained national CMA, CNAS, A2LA, FDA ASCA and CBTL laboratory

accreditation now. In addition, DEKRA is EU's medical device Notified Bodies - NB 0344 and NB 0124. We can provide certification

services for almost all products under EU medical device regulations. Authorized by MDSAP, DEKRA can also provide

comprehensive MDSAP audit service, which can help medical device manufacturers meet market access requirements efficiently.

DEKRA德凱作為全球領先的檢驗檢測認證機構，在醫(yī)療檢測領域快速發(fā)展，DEKRA德凱測試中心擁有專業(yè)的測試團隊，現(xiàn)已具備醫(yī)療器械國家

級CMA、CNAS、A2LA、FDA ASCA、CBTL的檢驗資質。此外，DEKRA德凱是歐盟的醫(yī)療器械公告機構NB 0344和NB 0124，醫(yī)療器械認可范疇幾

乎覆蓋所有歐盟醫(yī)療器械法規(guī)的所有產品。DEKRA德凱獲得醫(yī)療器械單一審核程序（MDSAP）的授權認可，可提供全面的MDSAP審核服務，助

力醫(yī)療設備制造商順利完成審核及認證服務，高效滿足市場準入要求。

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美國 America

德國 Germany

英國 UK

荷蘭 Netherlands

以色列 Israel

中國 China

日本 Japan

巴西 Brazil

熱線 Hotline: 400 688 1925

郵箱 Email: info@dekra.com.cn

網站 Website: www.dekra.com.cn

DEKRA德凱亞太區(qū)

DEKRA Asia Pacific

Scan the QR code to follow

DEKRA WeChat official account,

and reply \"Medical\" to get the e-book version.

2024.11