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全球检测认证领导者Applus+，总部位于西班牙（中国总部上海），在北美、欧洲、亚洲运营多类型实验室与认证机构，提供一站式测验、检验及产品与体系认证服务。旗下子公司德检(江苏)检测技术有限公司（Applus+De.testing）是专注医疗器械检测检验的第三方实验室，持国家级CMA、CNAS及国际IAS、A2LA认证资质，聚焦骨科/齿科植入物、有源医疗器械、医疗软件及网络安全等产品检测检验，为医疗器械在FDA、CE-MDR、NMPA等监管条件下的检测认证提供解决方案。
Applus+ is a global leader in testing, inspection, and certification (TIC), headquartered in Spain with its China headquarters in Shanghai. The company operates a wide network of laboratories and certification bodies across North America, Europe, and Asia, offering comprehensive one-stop services including product testing, inspection, certification, and management system audits. Its subsidiary, Applus (Jiangsu) Testing Co., Ltd. (Applus+De.testing), is a third-party laboratory specializing in medical device testing and inspection. Accredited with national-level CMA and CNAS as well as international IAS and A2LA certifications, the lab focuses on orthopedic and dental implants, active medical devices, medical software, and cybersecurity. It provides end-to-end testing and certification solutions tailored to regulatory requirements such as FDA, CE-MDR, and NMPA.
无源医疗器械 / NON ACTIVE MEDICAL DEVICES :
+ 磨损测试 / Wear testing
+ 疲劳试验 / Fatigue testing
+ 微动腐蚀 / Fretting corrosion testing
+ 加速老化 / Accelerated aging testing
+ 最坏情况选择分析(FEA) / Finite Element Analysis (FEA) for worst-case scenario selection
+ 材料学分析 / Material science analysis
+ 破坏分析 / Failure analysis
+ 材料和涂料 / Materials and coatings
有源医疗器械 / ACTIVE MEDICAL DEVICES :
+ 关键性能实验 / Key performance testing
+ 电气安全试验 / Electrical safety testing
+ 电磁兼容试验 / Electromagnetic compatibility (EMC) testing
+ 环境试验 / Environmental testing
软件&网络安全 / Software&Cybersecurity :
+ 渗透测试 / Penetration testing
+ 漏洞测试 / Vulnerability testing
+ 安全要求验证 / Safety requirement verification
+ 威胁缓解验证 / Threat mitigation verification
+ 软件功能验证 / Software functionality verification
+ NMPA注册检 / NMPA registration testing
CE-MDR认证 / CERTIFICATION
在欧盟销售产品须符合欧洲法规指令的技术与安全标准，制造商需确保产品合规并使用 CE 标志，医疗器械领域需符合 EU MDR 2017/745 法规以保障安全、可靠与可追溯性。我们以 Applus + 为统一联络机构，为客户提供检测认证服务，助其产品快速获得 CE 标记及合格证书。
For products marketed in the EU, manufacturers must ensure compliance with EU regulations/directives and use CE marking. Medical devices must meet EU MDR 2017/745 for safety, reliability, and traceability. Applus+ provides testing and certification services as a single contact point to help clients obtain CE marking and certificates efficiently.
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