The lifespan of medical devices and clinical assets depends on a number of factors, including frequency of use, maintenance and servicing, the way in which it's used, and more. However, under normal operating conditions, most connected medical devices have an estimated useful life of7-10 years...
内容提示: 龙德出品REGULATION (EU) 2017/745 欧盟医疗器械法规龙德医疗器械工具丛书医疗器械法规中英文对照系供内部学习使用欧盟医疗器械法规(Regulation (EU)2017/745) 中英对照版EU Medical Device Regulations(Regulation (EU) 2017/745)法规原文发布日期 2017 年 5 月 5 日第一版(2019 年 7 月)主编:杨龙 赵...
Learn more about medical device labeling regulations, including Unique Device Identifier (UDI), electronic Information for Use (eIFU) and the differences between regulations in the US, EU and China.
A Comparative Analysis of Medical Device Regulations in the EU and the USAAnnMarie Jahn
Since its initial publication, IEC 60601-1 has undergone several updates to reflect advances in technology, changes in regulatory requirements, and improvements in safety assessments for medical devices. The current edition of IEC 60601-1 is Edition 3.2 and is internationally recognized and accepted by...
If you currently produce and/or sell medical devices or in-vitro medical devices, you will need to be compliant with the new regulations, their processes and be able to present all documentation that is legally required within the respective time frames.
Study on the Establishment and Implementation of the Quality System Regulations for Medical Devices in China The importance of quality system regulations (QSR) for the medical devices is outlined,the status and progress in the medical devices QSR in China and abro... LM Wang,S Food,Drug ...
REGULATIONS IN PLACE The new EU medical devices guidance documents (MEDDEVs)4should be understood as supporting and clarifying existing directives. Therefore, according to a representative from Swiss Medic, the competent authority for medication and medical device manufacturers in Switzerland, notified bodi...
The European Commission expects the regulations to improve the quality, safety and reliability of medical devices, while also strengthening the transparency of information for consumers and enhancing the vigilance and market surveillance. 展开 年份: 2018 ...
Regulatory news for medical devices in Asia Get the latest medical device regulatory news in Asia. View all news Regulatory Update Aug 10, 2023 Malaysia Medical Device Regulator MDA Revises Consultancy Services The Malaysia Medical Device Authority (MDA) updated its consultancy services (August 2, ...