1. Medical Device(医疗器械): 指仪器、设备、器具、机器、用具、植入物、体外试剂或其他类似或相关物品,包括任何组件、零件或附件,其主要预期用途是用于人类疾病或其他状况的诊断、治疗、缓解、预防或监测,或者旨在影响人体的结构或功能。 2. Class I/II/III(I/II/III 类医疗器械): FDA 根据风险程度将医疗器械...
注册人必须是有一家在HSA注册的新加坡公司,并持有ACRA证书。注册人不需要HSA的许可证,但必须在Medical Device Information Communication System中注册。 所有的医疗器械必须由注册人提交,注册人进行提交并负责上市后的一些活动。 注册人还需要监管控制制造商在新加坡的授权进口名单,如果注册人是独立第三方,需要对分销商或...
1. Introduction Edge detectors are a very important class of filters used for identifying sharp variations for different image processing applications, including but not limited to object recognition, motion analysis, pattern recognition, and medical image processing, among others. As a consequence, ...
Medical Device unique customers since inception 750,000+ Records Submitted to FDA Global UDI Database 15+ Years of Structured Product Labeling Experience 1,000+ Pharmaceutical customers including manufacturers 99.95% Pharma FDA SPL submissions delivered within contracted time ...
Date of Patent: August 1, 2017 Assignee: Microsoft Technology Licensing, LLC Inventors: Sandeep Kanumuri, Naveen Thumpudi Displaying image thumbnails in re-used screen real estate Patent number: 9699351 Abstract: Methods, system and computer-readable media are disclosed to facilitate presenting...
Keywords: class-S power amplifier; wide band; power amplifier; ultrasound system 1. Introduction An increasing number of industrial fields are currently employing ultrasonic devices [1]. In the medical field, ultrasonic devices are used to examine the internal organs, and confirm the presence of ...
1. Medical Device(医疗器械): 指仪器、设备、器具、机器、用具、植入物、体外试剂或其他类似或相关物品,包括任何组件、零件或附件,其主要预期用途是用于人类疾病或其他状况的诊断、治疗、缓解、预防或监测,或者旨在影响人体的结构或功能。 2. Class I/II/III(I/II/III 类医疗器械): ...
1. Medical Device(医疗器械): 指仪器、设备、器具、机器、用具、植入物、体外试剂或其他类似或相关物品,包括任何组件、零件或附件,其主要预期用途是用于人类疾病或其他状况的诊断、治疗、缓解、预防或监测,或者旨在影响人体的结构或功能。 2. Class I/II/III(I/II/III 类医疗器械): ...