[对医疗器械临床评估等价证明技术的简要分析]
Huanhuan Tian1, Sujing Wu1, Yu Liang2
1Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299.
概括
证明医疗器械的同等性至关重要,特别是对于免于临床评估的设备. 本研究阐明了复杂的等价原则和监管专业人士的实际挑战.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 生物相容性和材料科学
- 临床评估策略 临床评估策略
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