When product safety, regulatory compliance, and global delivery all depend on content, technical content must evolve.
在医疗器械行业,技术内容不仅是“说明书”,更直接关系到产品的安全使用、法规合规、临床支持与全球市场准入。
In the medical device industry, technical content is not just documentation — it directly affects safe use, regulatory compliance, clinical support, and global market access.
但在很多企业中,技术内容体系仍停留在“文档层面”。
But in most companies, technical content systems still remain at the level of manuals.
你是否正在面对这些真实问题?
This is not just a documentation problem. It is a compliance, safety, and system capability problem.
在医疗器械行业,技术内容正在直接影响:
Why technical content is harder in medical devices
Leading companies are doing this.
Professionals from medical device industry are already joining tcworld China 2026
以下企业的专业人士已经参与 tcworld China 2026:
Professionals from the following companies are already joining tcworld China 2026:
这些企业面临的共同挑战是:严格法规、多语言交付、复杂产品与高风险使用场景所带来的高要求技术内容体系。
These companies share similar challenges: strict regulations, multilingual delivery, complex products, and the need for highly reliable technical content in high-risk usage scenarios.
Selected sessions relevant to medical device industry
From Manual Team to AI Transformation Pioneer
By 汪媛媛 技术内容开发部负责人,联影医疗;闫贺丽 高级技术文档工程师,联影医疗
医疗设备企业正面临从“文档支持”到“内容驱动产品体验”的转型。
该议题展示如何将传统文档团队升级为 AI 驱动的内容体系核心力量,
对正在探索 AI 应用与内容体系升级的医疗器械企业具有高度参考价值。
Medical device companies are shifting from documentation support to content-driven product experience.
This session shows how documentation teams evolve into AI-driven content organizations,
providing valuable insights for companies exploring AI-enabled content transformation.
EU MDR 2017/745: Key Labeling Requirements and Practical Examples
By Paola Maria Brunello 首席标签专家,史赛克
欧盟医疗器械法规对标签与信息提出了严格要求,
直接影响产品注册、市场准入与合规风险控制。
该议题结合实际案例解析法规要求,适合面向欧洲市场的医疗器械企业。
EU MDR imposes strict requirements on labeling and information,
directly affecting product registration, market access, and compliance risks.
This session provides practical insights for companies targeting the European market.
End-to-End Digital Compliance Validation: Integrating CMS with OA Systems
By Fiona Lin 技术文档部门负责人,制药设备公司
医疗与制药设备行业对内容的可追溯性与审批流程要求极高,
该议题展示如何通过系统集成实现内容合规验证的流程化与数字化,
提升效率同时满足审计与监管要求。
Medical and pharmaceutical industries require strong traceability and approval workflows.
This session shows how system integration enables digital compliance validation,
improving efficiency while meeting audit and regulatory requirements.
Clarity Saves Lives: Simplified Technical English to Reduce Human Error Risks
By Daniela Zambrini 技术文档工程师,eXeL8
在医疗器械领域,内容的清晰性直接关系到用户安全与操作风险。
该议题探讨如何通过简化技术语言降低误操作概率,
对高风险使用场景的设备企业尤为关键。
In medical devices, content clarity directly impacts user safety and risk reduction.
This session explores how simplified technical English reduces human error,
which is critical for high-risk usage scenarios.
→ 查看完整议程 / Explore the full program
Who should attend
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