96831 是悉尼科技大学（University of Technology Sydney，UTS）的一门课，开设在Faculty of Health，属于 Graduate School of Health 领域。这一页汇总它的课程目录信息和UTS学生留下的评价。
中文课名：医疗器械：法规与质量体系要求
课程类型：Postgraduate subject
学分：6
课程领域：Graduate School of Health
所属学院：Faculty of Health
层级：Postgraduate
目录年份：2026
This subject equips you with an industry focused foundation in the growing Medical Device industry to broaden your skill base. Regulatory pathways and quality management systems for medical devices in the major global markets including US, EU and Australia will be studied using ISO 13485:2016 Medical Devices - Quality Management Systems, FDA 21 CFR Part 820 - Quality System Regulation and ISO 14971 Medical Devices - Application of Risk Management as the basis for the devel…
还没有UTS学生给 96831 写过评价。有人写了之后，这里会显示实用性、难度（difficulty）、推荐度和具体的课程体验——在那之前它是空的，不会用生成内容填满。
独立学生社区，与悉尼科技大学官方无隶属关系。