NMPA · EU MDR · FDA
医疗器械法规事务，
以及为此写的软件。
Regulatory affairs for medical devices,
and the software written for that work.
自 2007 年起做中国注册、欧盟技术和美国申报。近年来广泛关注 AI 技术，并将其应用到合规及其他感兴趣的领域。
Registration and submissions since 2007, across China, Europe and the United States. In recent years, a broad interest in AI, applied to compliance and to other fields.
独立顾问。为厂家、经销商和咨询公司处理 NMPA、EU MDR 与 FDA 项目，把三条路径的差别讲清楚，并把注册做完。
Independent consultant. NMPA, EU MDR and FDA work for manufacturers, distributors and consultancies. The differences between the three paths, and the submission itself.
把法规文本、标准和指南收成开放知识库，再让助手去写临床评价、分类和注册文档。仓库公开，站点可检索。
Regulations, standards and guidance collected into an open knowledge base, then used by an assistant for clinical evaluation, classification and submission documents.
美股与宏观研究，公开的部分是子午宏观：在数据发布前给出预测，再用官方第一次公布值打分。系统用编程代理写成并部署。
US equities and macro research. The public piece is Meridian Macro: a forecast before the release, scored against the first official print. The systems are written with coding agents and deployed.
NMPA、EU MDR、FDA。人工智能软件、手术机器人、脉冲电场消融、可穿戴、胰岛素泵、影像与眼科等注册项目。
NMPA, EU MDR and FDA. Registrations including AI software, surgical robots, pulsed field ablation, wearables, insulin pumps, imaging and ophthalmology.
QA/RA Lead。机器学习影像软件的 NMPA、CE 与 FDA，主要在中国注册，并补齐创业公司的质量和申报文件。
QA/RA Lead. NMPA, CE and FDA for machine-learning imaging software, mostly China, including the quality system and submission files for a startup.
顾问。欧盟 MDR 技术文档与临床评价，FDA 510(k)，以及面向客户的 NMPA / MDR 培训和法规策略。
Consultant. EU MDR technical documentation and clinical evaluation, FDA 510(k), and regulatory strategy and training for NMPA and MDR.
高级法规专员，西门子医疗体系。直线加速器、近距离治疗和软件的中国注册，以及与审评机构的技术沟通。
Senior RA specialist, a Siemens Healthineers company. China registration for linear accelerators, brachytherapy and software, including technical meetings with reviewers.
高级法规专员。脑深部电刺激系统相关产品的中国注册。
Senior RA specialist. China registration for deep-brain stimulation products.
法规经理。影像引导手术、放疗和数字化手术室的 NMPA 注册与 CCC。七年里取得多项新注册、变更和延续。
RA manager. NMPA registration and CCC for image-guided surgery, radiotherapy and digital operating rooms. New licences, a change approval and renewals.
法规、质量与标准化。放射影像工作站软件的 NMPA、FDA 与 CE，临床试验，以及 RSNA、ECR 的国际事务。
RA, QA and standardization. NMPA, FDA and CE for radiology workstation software, clinical trials, and international work including RSNA and ECR.