O--changeofthebatteryunitP--functionindicator Q--entryrejectedR--externalcontrol 51.()计费时间()非高峰时间 点击查看答案 第3题 Task 4 Directions: The following is a list of medical terms. After reading it, you are required to find the items equivalent to (与…等同) those given in Chines...
4. Information Technology: IEC standards cover various aspects of information technology, including data communication protocols, software safety, and cybersecurity. Standards like IEC 62304 for medical device software and IEC 62443 for industrial automation and control systems' security ensure the reliabili...
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114). CDRH...
The article reports on the two new standards that Health Canada added to the list of recognized standards for use in medical devices which include two IEC standards for medical electrical equipment and one ISO standard f...
Furthermore, we prioritize the confidentiality and protection of personal data, strictly adhering to privacy regulations such as GDPR, CAN-SPAM, CASS, CCPA, CASL, and other relevant standards. Your marketing endeavors will be conducted ethically and lawfully, ensuring compliance with industry guidelines...
Task D Directions: The following is a list of terms related to the supply chain. After reading it, you are required to find the items equivalent to those given in Chinese in the table below. Then you should mark the corresponding letters with a single letter through the center in order ...
Food and Drug Administration (FDA) announcing the modifications to the list of standards FDA used in premarket reviews to meet requirements for medical devices. The notice invites public comments which are to be sent to FDA in Maryland. Tables entitled Modification to the list of recognized ...
Define substantialist. substantialist synonyms, substantialist pronunciation, substantialist translation, English dictionary definition of substantialist. n 1. the doctrine that a substantial reality underlies phenomena 2. the doctrine that matter is a r
ISO 13485 certified manufacturers have established compliance to ISO 9001, and must fulfill other requirements specific to the manufacture of medical components and equipment. According to ISO.org, the ISO 13485 certification applies to those involved in the design, production, installation, and ...
The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate 为达到本附录第 10.4 条 的目的,委员会应尽快并于 2018 年 ...