招商大使简介—迈克尔·雅各比

Michael Jacobi, born on 6th June 1988 in Germany, currently resides in Duisburg. Mr. Jacobi is proficient in regulatory standards including ISO 13485:2016, 93/42 EWG/RL, 2017/745 EU - MDR, the EU-GDP Directive, and 21 CFR 820. His expertise includes the execution of internal audits in quality and medical fields and the development of comprehensive management systems, essential for ensuring compliance and operational efficiency in investment projects.

During his employment at a notified body of the National Association Statutory Health Insurance Funds and a TUV branch he gained experience in regulatory compliance and governmental-accredited certification procedures. Mr. Jacobi is actively engaged in several investment projects in the Hainan region, China, collaborating closely with the Hainan Region to advance these initiatives. He has successfully managed projects within a wide scope, demonstrating his capability in project realization and management.

Mr. Jacobi's academic credentials include legal studies in Tübingen (Germany), with a focus on public international law and international commercial law. He has attained several professional certifications and advanced training, including auditor certification from certification bodies. These qualifications equip him to navigate complex regulatory landscapes and implement robust quality management systems, crucial for the successful commercialization of medical devices.

Further enhancing his qualifications, Mr. Jacobi has participated in the German Congress for Energy Efficiency, received advanced training as a lead auditor for ISO 9001:2015, and completed training for IATF 16949:2016. He is certified as a data protection officer according to DSC Standard. His extensive expertise aim for compliance of medical device projects with quality and safety standards as well as best practices in data protection and energy efficiency.

The ongoing collaboration with the Hainan Region highlights the ability to enhance operational efficiency, and facilitate market access for innovative medical devices in this key region.

The "Investment Promotion Ambassador" makes a commitment to:

I Michael Jacobi, volunteer as the "Investment Ambassador" of Hainan Provincial Department of Industry and Information Technology, and give full play to my professional and resource advantages to attract investment and talents for Hainan Province. Do not use this identity to carry out matters unrelated to the work, do not do illegal, illegal or disciplinary matters, maintain the image of Hainan Province and the Provincial Department of Industry and Information Technology, and make contributions to accelerating the construction of Hainan Free Trade Port!

迈克尔·雅各比（Michael Jacobi），1988年6月6日出生于德国，现居杜伊斯堡。雅各比先生熟悉ISO 13485:2016、93/42 EWG/RL、2017/745 EU-MDR、EU-GDP 指令和21 CFR 820等各类药械监管标准，善于开展项目质量和医疗领域的内部审核，擅长开发全面的项目管理系统，能够提供投资项目的合规性审查和运营效率提升等重要服务。

雅各比先生在全国协会法定健康保险基金通知机构和TUV分公司工作期间，积累了丰富的合规性和政府认可认证程序方面的经验，有较强的项目实施和管理能力，曾参与海南的多个投资项目，并成功管理过不同领域多个项目。

雅各比先生曾在德国图宾根大学攻读法律学专业，主修国际公法和国际商法。参加过多项高级培训，并获得多项专业认证，包括认证机构的审计师认证等。这些资质使他能够驾驭复杂的监管环境，实施稳健的质量管理体系，这对医疗器械的成功商业化至关重要。

雅各比先生参加过德国能效大会，参加并完成了ISO 9001:2015主任审核员高级培训和IATF 16949:2016培训，获得DSC标准的数据保护官认证。其丰富的专业知识能有效地使医疗器械项目符合质量和安全标准，并能出色地开展数据保护和能效方面的工作。

雅各比先生与海南地区的合作，凸显了其项目运营和促进创新医疗器械市场准入的能力。

“招商大使”承诺：

本人Michael Jacobi，自愿作为海南省工信厅“招商大使”，发挥专业和资源方面的优势，为海南省招商引资、招才引智。不利用该身份开展与工作无关事宜，不做违法、违规、违纪之事，维护海南省和省工信厅的形象，为加快推进海南自由贸易港建设作出贡献！