随着全球医疗器械监管环境的日益严苛,尤其是欧盟医疗器械法规(MDR)的深入实施以及ISO 10993-1:2025生物安全评价标准的更新,企业面临着前所未有的合规挑战。
从临床评价的严谨性到化学表征的复杂性,再到日益凸显的网络安全(Cybersecurity)风险,如何精准把握法规脉搏、构建高效的安全评价体系,已成为医疗器械企业出海及高质量发展的关键命题。
在此背景下,Applus+ Laboratories 携手 德生检测,定于 2026年7月24日在济南共同举办“欧盟医疗器械法规合规与安全评价技术研讨会”。为参会企业提供最具实操性的合规升级路径与解决方案,助力企业在激烈的市场竞争中稳健前行。
时间:
2026年7月24日(星期五)
地点:
山东省济南市 济南火车站希尔顿欢朋酒店
活动议程:
8:30-8:55: 签到
9:00-9:05: 开场致辞
9:05-10:05: ISO 10993-1:2025生物安全评价核心变化梳理与企业有效的升级路径分享
10:30-11:30: 欧盟医疗器械法规MDR (CE) 合规战略
13:30:14:30: 医疗器械化学表征检测要点及案例分享
14:50-15:50: MDR (CE) 网络安全项目案例和测试解析
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