Help enterprises eliminate trade barriers and solve all problems of medical device registration
Clinical Trial/Clinical Evaluation
In collaboration with Istinye University Hospital Liv Hospital Bah?e?ehir 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
Llins 凌甫科技--共創(chuàng)團隊精神，攀越巔峰，溫泉暢享！
凌甫科技2023年度團建回顧
2024-09-23 2024-09
新加坡醫(yī)療器械注冊流程詳解 凌甫科技繼在英國、美國、德國成立公司后，于2024年9月17日宣布在新加坡設(shè)立新公司。
2024-06-01 2024-06
FDA 510(k)認(rèn)證證書六連捷 凌甫科技傾力協(xié)助合作伙伴成功斬獲電磁刺激系統(tǒng)、氣腹針、帶過濾的藥瓶適配器等六款產(chǎn)品的FDA 510(k)認(rèn)證！
2024-05-10 2024-05
凌甫科技助力合作伙伴斬獲 Intertek 簽發(fā)的獨立軟件 MDR CE證書 凌甫科技與合作伙伴在醫(yī)療器械軟件MDR認(rèn)證領(lǐng)域取得突破，成功獲得Intertek簽發(fā)的IIb類獨立軟件MDR CE證書
2024-04-07 2024-04
第89屆 CMEF 中國國際醫(yī)療器械（春季）博覽會--上海站 凌甫科技誠邀您蒞臨展位7.1T33
2024-04-02 2024-04
凌甫科技助力常州雙馬斬獲DEKRA MDR CE證書！ 凌甫科技助力常州雙馬斬獲DEKRA 一次性使用無菌自毀注射器等六大輸注類產(chǎn)品 MDR CE證書
2024-03-01 2024-03
凌甫科技邀您相約2024重慶CACLP展會 凌甫科技誠邀您蒞臨博覽會，前往N5-0530號展位參觀商談
第二類醫(yī)療器械注冊證的申請流程
2024-09-09 2024-09
Eudamed上不同賬號的功能權(quán)限介紹 Eudamed 上制造商常見的賬號有 LAA 賬號和 LUA賬號，那么這些賬號之間的關(guān)聯(lián)和權(quán)限會是如何呢？
2024-08-20 2024-08
第二個LAA賬號的申請步驟 本篇是申請第二個LAA賬號的步驟教程，第三個LAA賬號，第四個等的LAA賬號步驟與第二個申請的步驟一樣
2024-07-29 2024-07
馬來西亞醫(yī)療器械注冊流程解讀 從這次歐盟MDR新規(guī)新增的部分我們可以看出，MDR新規(guī)在分類上對舊MDD法令進行了進一步細化，對于一些原本模糊的分類進行了邊界清晰界定，
2024-07-04 2024-07
沙特醫(yī)療器械注冊審批流程解讀 近日，凌甫科技與其合作伙伴經(jīng)過共同努力，成功獲得了沙特SFDA注冊證書，這一成就將有力推動合作伙伴順利進入并拓展中東市場。
2024-06-21 2024-06
美國FDA醫(yī)療器械注冊流程：從分類到上市后的每一步 在全球醫(yī)療器械市場中，美國是一個至關(guān)重要的市場。為了能夠合法進入美國市場，醫(yī)療器械必須通過美國食品藥品監(jiān)督管理局（FDA）的注冊。本文將為您詳細介紹FDA醫(yī)療器械注冊的流程和注意事項。
2024-05-27 2024-05
體外診斷（IVD）WHO預(yù)認(rèn)證 世衛(wèi)組織于2010年啟動的體外診斷資格預(yù)審（Prequalification，PQ）認(rèn)證，旨在為資源有限的國家提供質(zhì)量保證、經(jīng)濟上可承擔(dān)的診斷技術(shù)和試劑
《公告》指出：2024年6月1日起生產(chǎn)的醫(yī)療器械，在其上市銷售前，注冊人應(yīng)當(dāng)按照相關(guān)標(biāo)準(zhǔn)或者規(guī)范要求將最小銷售單元、更高級別包裝的產(chǎn)品標(biāo)識和相關(guān)數(shù)據(jù)上傳至醫(yī)療器械唯一標(biāo)識數(shù)據(jù)庫，確保數(shù)據(jù)真實、準(zhǔn)確、完整、可追溯。
2024-08-02 2024-08
FDA公布2025財年收費標(biāo)準(zhǔn) 當(dāng)?shù)貢r間2024年7月31日，F(xiàn)DA公布了2025財政年度醫(yī)療器械用戶收費標(biāo)準(zhǔn)，2025財年收費標(biāo)準(zhǔn)費用執(zhí)行時間為2024年10月1日至2025年9月30日。
2024-07-25 2024-07
澳大利亞TGA官方費用已更新 2024年7月1日起，澳大利亞TGA對醫(yī)療器械的申請費和年費進行了更新
2024-01-04 2024-01
全是干貨資料，臨床研究指南更新！！ 歐盟臨床研究指南更新，CE MDR EUDAMED MDSAP
2023-12-05 2023-12
歐盟指定D類高風(fēng)險體外診斷醫(yī)療器械參考實驗室 2023年12月6日，歐盟委員會發(fā)布了（EU）2023/2713號實施條例，該條例主要是關(guān)于制定體外診斷醫(yī)療器械領(lǐng)域的歐盟參考實驗室。
2023-12-04 2023-12
【下篇】FDA關(guān)于電外科器械警告事項的特殊要求 對于單極電外科器械，還需在說明書的警告事項中另加上以下幾條（如適用）
2023-12-01 2023-12
突發(fā)！中國制造塑料注射器因安全問題被FDA點名，將影響我國此類產(chǎn)品進入美國市場 2023年11月30日，F(xiàn)DA發(fā)布一則安全通訊，表示FDA正在收集和分析數(shù)據(jù)，以評估中國制造的塑料注射器出現(xiàn)器械故障（如泄漏、破損和其他問題）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 Bah?e?ehir 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
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