Help enterprises eliminate trade barriers and solve all problems of medical device registration
Clinical Trial/Clinical Evalua
In collaboration with Istinye University Hospital Liv Hospital Bahçeşehir in Turkey, with an exclusive cooperative clinical laboratory.
Provide comprehensive solutions such as clinical protocol design, clinical data information processing, process-based project management, electronic collection of customer requirements, systematic logistics management, etc.
Provide high quality clinical evaluation reports
EU Market
Provide CE technical document writing, system guidance, test docking and other complete solutions
Provide EU Authorized Representative service, EU Free Sale Certificate (FSC), ISO14971 risk analysis, clinical evaluation, sterilization, software cycle, usability and other EU compliance consulting and services
USA Market
Provide 510K document writing, product listing, factory site registration, US agent, US CFG, UDI, DeNovo, PMA and other compliance consulting and services
Chinese Market
Provide NMPA technical document writing, production license, innovative medical device declaration and other compliance consulting and services
Quality Management System
ISO 13485 quality system training, establishment and operation guidance.
NMPA(GMP, GSP) quality system training, establishment and operation guidance.
MDSAP quality system training, establishment and operation guidance.
FDA CFR820 quality system training, establishment and operation guidance.
Quality system routine maintenance services, EU CAPA, process improvement, outsourcing of quality system maintenance, supplier audit.
Authorized Representatives Services
EU Authorized representative
UK Authorized representative
USA Authorized representative
Switzerland Authorized representative
Saudi Arabia Authorized representative
Australia Authorized representative
凌甫科技2023年度团建回顾
2024-09-23 2024-09
新加坡医疗器械注册流程详解 凌甫科技继在英国、美国、德国成立公司后，于2024年9月17日宣布在新加坡设立新公司。
2024-06-01 2024-06
FDA 510(k)认证证书六连捷 凌甫科技倾力协助合作伙伴成功斩获电磁刺激系统、气腹针、带过滤的药瓶适配器等六款产品的FDA 510(k)认证！
2024-05-10 2024-05
凌甫科技助力合作伙伴斩获 Intertek 签发的独立软件 MDR CE证书 凌甫科技与合作伙伴在医疗器械软件MDR认证领域取得突破，成功获得Intertek签发的IIb类独立软件MDR CE证书
2024-04-07 2024-04
第89届 CMEF 中国国际医疗器械（春季）博览会--上海站 凌甫科技诚邀您莅临展位7.1T33
2024-04-02 2024-04
凌甫科技助力常州双马斩获DEKRA MDR CE证书！ 凌甫科技助力常州双马斩获DEKRA 一次性使用无菌自毁注射器等六大输注类产品 MDR CE证书
2024-03-01 2024-03
凌甫科技邀您相约2024重庆CACLP展会 凌甫科技诚邀您莅临博览会，前往N5-0530号展位参观商谈
第二类医疗器械注册证的申请流程
2024-09-09 2024-09
Eudamed上不同账号的功能权限介绍 Eudamed 上制造商常见的账号有 LAA 账号和 LUA账号，那么这些账号之间的关联和权限会是如何呢？
2024-08-20 2024-08
第二个LAA账号的申请步骤 本篇是申请第二个LAA账号的步骤教程，第三个LAA账号，第四个等的LAA账号步骤与第二个申请的步骤一样
2024-07-29 2024-07
马来西亚医疗器械注册流程解读 从这次欧盟MDR新规新增的部分我们可以看出，MDR新规在分类上对旧MDD法令进行了进一步细化，对于一些原本模糊的分类进行了边界清晰界定，
2024-07-04 2024-07
沙特医疗器械注册审批流程解读 近日，凌甫科技与其合作伙伴经过共同努力，成功获得了沙特SFDA注册证书，这一成就将有力推动合作伙伴顺利进入并拓展中东市场。
2024-06-21 2024-06
美国FDA医疗器械注册流程：从分类到上市后的每一步 在全球医疗器械市场中，美国是一个至关重要的市场。为了能够合法进入美国市场，医疗器械必须通过美国食品药品监督管理局（FDA）的注册。本文将为您详细介绍FDA医疗器械注册的流程和注意事项。
2024-05-27 2024-05
体外诊断（IVD）WHO预认证 世卫组织于2010年启动的体外诊断资格预审（Prequalification，PQ）认证，旨在为资源有限的国家提供质量保证、经济上可承担的诊断技术和试剂
《公告》指出：2024年6月1日起生产的医疗器械，在其上市销售前，注册人应当按照相关标准或者规范要求将最小销售单元、更高级别包装的产品标识和相关数据上传至医疗器械唯一标识数据库，确保数据真实、准确、完整、可追溯。
2024-08-02 2024-08
FDA公布2025财年收费标准 当地时间2024年7月31日，FDA公布了2025财政年度医疗器械用户收费标准，2025财年收费标准费用执行时间为2024年10月1日至2025年9月30日。
2024-07-25 2024-07
澳大利亚TGA官方费用已更新 2024年7月1日起，澳大利亚TGA对医疗器械的申请费和年费进行了更新
2024-01-04 2024-01
全是干货资料，临床研究指南更新！！ 欧盟临床研究指南更新，CE MDR EUDAMED MDSAP
2023-12-05 2023-12
欧盟指定D类高风险体外诊断医疗器械参考实验室 2023年12月6日，欧盟委员会发布了（EU）2023/2713号实施条例，该条例主要是关于制定体外诊断医疗器械领域的欧盟参考实验室。
2023-12-04 2023-12
【下篇】FDA关于电外科器械警告事项的特殊要求 对于单极电外科器械，还需在说明书的警告事项中另加上以下几条（如适用）
2023-12-01 2023-12
突发！中国制造塑料注射器因安全问题被FDA点名，将影响我国此类产品进入美国市场 2023年11月30日，FDA发布一则安全通讯，表示FDA正在收集和分析数据，以评估中国制造的塑料注射器出现器械故障（如泄漏、破损和其他问题）的可能性。
Since its establishment in 2017, Lingfu Technology has always focused on providing professional, efficient and customized technical consulting services for medical device manufacturers, and is committed to helping companies launch safe, effective and regulatory compliant products to the global market. The company is headquartered in Shanghai, and has branches and offices in Hangzhou, Germany, the UK and the US, which can provide medical device manufacturers with one-stop regulatory consulting services for their products before launch. The company's main technical services cover: IVDR overseas clinical trials, EU CE certification, US FDA registration, China NMPA registration consultation, system certification, and authorized representative services of various countries.
Lingfu Technology gathers many senior experts and elites from medical device regulations, clinical and other fields, most of them have rich working experience in well-known notified bodies and regulatory departments of famous domestic and foreign medical device enterprises, and have an average of more than 10 years of experience in medical device regulations. From research and development to market launch and subsequent marketing services, Lingfu Technology's professional team will provide you with all-round global regulatory support.
Relying on the strategic layout of independent operation, Lingfu Technology has successfully established three authorized representative service companies in the international market. LLINS Technology Ltd in the United Kingdom, LLINS TECHNOLOGY INC in the United States and Llins Service & Consulting GmbH in Germany, which realizes the globalization of the business layout. At the same time, Lingfu Technology adheres to the principle of open cooperation and has established an exclusive cooperative clinical laboratory with Istinye University Hospital Liv Hospital Bahçeşehir in Turkey, aiming to deepen the cooperation between the two sides in the field of clinical trials, provide customers with more accurate and efficient services, and jointly promote the development of technical services.
Deep cultivation of medical device industry, widely recognized and trusted by the industry
