Design for BetterDevice withUnderstandingPeople以理解用户为基础，设计更安全的医疗器械

Align human factors activities with your product development lifecycle, risk controls, and regulatory pathway.将人因工程活动与产品开发周期、风险控制和注册路径协调起来。

Run iterative usability testing early, so design teams can find use problems before they become expensive.在早期开展迭代式可用性测试，帮助团队尽早发现并修正使用问题。

Plan and execute rigorous summative testing to demonstrate safe and effective use for regulatory submission.规划并执行严谨的总结性验证测试，支持安全有效使用的注册证据。

Prepare usability engineering files and human factors documentation for NMPA, FDA, and global expectations.准备可用性工程文件和人因相关资料，面向 NMPA、FDA 及国际监管要求。

Identify critical tasks, use errors, and mitigation opportunities across devices, instructions, and environments.识别关键任务、使用错误和缓解机会，覆盖设备、说明材料与使用环境。

Create clear IFUs, quick reference guides, and training materials that help intended users act with confidence.设计清晰的 IFU、快速参考指南和培训材料，帮助目标用户更有信心地操作。