MedTech · FinTech · Vibe Coding
医疗器械合规与量化研究，以及支撑两者的软件开发。
Medical device compliance and quantitative research, and the software that supports both.
自 2007 年起从事医疗器械注册工作，涉及中国 NMPA、欧盟 MDR 与美国 FDA。近年来，将 AI 技术引入合规文档工作，并延伸至量化研究领域。
Regulatory work for medical devices since 2007, covering NMPA in China, EU MDR and US FDA. In recent years, AI has been brought into compliance documentation and extended into quantitative research.
目前以独立顾问身份，为生产企业、经销商和咨询机构提供 NMPA、欧盟 MDR 与 FDA 注册服务。三个体系的监管思路各有差异，项目启动时先厘清这些差异，再推进申报。
Independent consulting for manufacturers, distributors and consultancies, covering NMPA, EU MDR and FDA registration. The three systems differ in regulatory approach. A project begins by clarifying those differences, then moves the submission forward.
DocMCP 是一套开放的法规知识库，收录 EU MDR、FDA、NMPA 的法规与指南，以及相关国际标准，以 CC BY 4.0 协议发布，支持在线检索。ReguVerse 起草注册文档时即以这套资料为依据，收录范围仍在持续扩充。
DocMCP is an open regulatory knowledge base. It collects EU MDR, FDA and NMPA regulations and guidance, together with related international standards, and is published under CC BY 4.0 with online search. ReguVerse draws on this material when drafting submission documents, and the collection continues to grow.
子午宏观是对外开放的宏观预测工具，在数据公布前一天给出初请失业金、CPI、PPI、PCE、非农就业和 GDP 的预测，官方首次公布后再与实际值对照评分。
Meridian Macro is a public macroeconomic forecasting tool. It issues forecasts for jobless claims, CPI, PPI, PCE, nonfarm payrolls and GDP the day before release, then scores them against the first official print.
另有一套自用的交易工具：美股侧重判断股价所处阶段、突破形态与相对强弱，加密货币则在回踩时寻找入场点，仓位依据账户可承受的风险确定。
A separate trading tool is kept for private use. For US equities it reads the price stage, breakout structure and relative strength. For crypto it looks for entries on pullbacks. Position size follows the risk the account can bear.
参与技术文档与临床评价工作，涉及 AI 软件、骨科手术机器人、脉冲电场消融、可穿戴设备、胰岛素泵与血糖仪、强脉冲光设备和透明质酸填充剂。
Contributed to technical documentation and clinical evaluation, covering AI software, orthopedic surgical robots, pulsed field ablation, wearables, insulin pumps and glucose meters, intense pulsed light devices, and HA fillers.
完成磁共振线圈的 510(k)，放射影像工作站软件获得美国许可，机器学习影像软件同时申报 CE 与 FDA。
Completed the 510(k) for MR coils. Radiology workstation software obtained US clearance. Machine-learning imaging software was filed for both CE and FDA.
涵盖直线加速器、近距离治疗与治疗计划软件、脑深部电刺激、影像引导手术、放疗和数字化手术室产品的中国注册，并包括相应的注册变更与延续。机器学习影像软件以中国注册为主。
Covers China registration of linear accelerators, brachytherapy and treatment-planning software, deep-brain stimulation, image-guided surgery, radiotherapy and digital operating rooms, including the related changes and renewals. Machine-learning imaging software is registered mainly in China.
在中国、欧盟和美国三个体系中均有注册经验，涉及的产品包括口腔手术机器人、共聚焦显微成像、血液灌流器、内窥镜、持续葡萄糖监测、CT 高压注射器、光学生物测量仪、体外心室辅助、PTA 球囊与导丝，以及呼吸麻醉设备。
Registration experience across China, the European Union and the United States, covering dental surgical robots, confocal imaging, hemoperfusion, endoscopes, continuous glucose monitoring, CT contrast injectors, optical biometers, ventricular assist devices, PTA balloons and guidewires, and anesthesia equipment.
上述系统均与编程助手协作完成，成稿后直接部署上线。法规知识库、子午宏观以及本站，都是以这种方式开发的，自用的交易工具亦然。
The systems above were developed with a coding assistant and deployed once complete. The regulatory knowledge base, Meridian Macro and this site were built in this way, as was the private trading tool.
提供 NMPA、EU MDR 和 FDA 注册服务，项目涉及 AI 软件、手术机器人、脉冲电场消融、可穿戴设备、胰岛素泵、影像与眼科产品。
Provides NMPA, EU MDR and FDA registration services, covering AI software, surgical robots, pulsed field ablation, wearables, insulin pumps, and imaging and ophthalmic products.
QA/RA 负责人，负责机器学习影像软件在中国、欧盟和美国的注册，以 NMPA 为主，同时补齐初创公司的质量体系与申报文件。
QA/RA Lead, responsible for registration of machine-learning imaging software in China, the European Union and the United States, principally with the NMPA, and for completing the startup’s quality system and submission files.
顾问，负责欧盟 MDR 技术文档、临床评价和 FDA 510(k)，并为客户提供 NMPA 与 MDR 的培训及法规策略咨询。
Consultant, responsible for EU MDR technical documentation, clinical evaluation and FDA 510(k), and for training and regulatory strategy on NMPA and MDR.
高级法规专员，负责直线加速器、近距离治疗产品和软件的中国注册，并与审评机构开展技术沟通。
Senior Regulatory Specialist, responsible for China registration of linear accelerators, brachytherapy products and software, and for technical communication with reviewers.
高级法规专员，负责脑深部电刺激系统相关产品的中国注册。
Senior Regulatory Specialist, responsible for China registration of deep-brain stimulation products.
法规经理，负责影像引导手术、放疗和数字化手术室产品的 NMPA 注册与 CCC 认证，涵盖新证获取、变更及延续。
Regulatory Affairs Manager, responsible for NMPA registration and CCC certification of image-guided surgery, radiotherapy and digital operating room products, covering new licences, changes and renewals.
法规、质量与标准化，负责放射影像工作站软件的 NMPA、FDA 与 CE，参与临床试验，并参与 RSNA、ECR 相关的国际事务。
Regulatory affairs, quality and standardization, responsible for NMPA, FDA and CE of radiology workstation software, and for clinical trials and international work including RSNA and ECR.