NB是CAB中被监管机构(national authority)指定的组织, 即A conformity assessment body officially designated by the national authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation。 NB的职责: · 根据ISO 13485认证质量管理体系和MDR执行“...
conformity assessment bodymeans a body that performs conformity assessment activities including calibration, testing, certification and inspection; conformity assessmentmeans the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; ...
Dealers or sales organisations who place medical devices on the market under their own name are, however, manufacturers in the meaning of the Medical Devices Directives and must conduct a corresponding conformity assessment procedure – regardless of what influence they have on the development and/or...
Definition of conformity in the Financial Dictionary - by Free online English dictionary and encyclopedia. What is conformity? Meaning of conformity as a finance term. What does conformity mean in finance?
内容提示: Conformity Assessment(合格评审) Certification of OEM Devices OEM 设备认证 Often identical medical devices are placed on the market under different manufacturers' names, although a single producer makes them. In such cases the company under whose name the device is placed on the market ...
Conformity assessment procedures Class A sole responsibility of the manufacturers not required to obtain manufacturing license shall register Class B notified body shall register Class C notified body apply for a license Class D notified body apply for a license ...
Conformity assessment procedures Class A sole responsibility of the manufacturers not required to obtain manufacturing license shall register Class B notified body shall register Class C notified body apply for a license Class D notified body apply for a license ...
Laboratory (hereinafter referred to as Lifud laboratory) has passed the site assessment of China National Accreditation Service for Conformity Assessment (hereinafter referred to as CNAS) and successfully obtained the laboratory accreditation certificate issued by CNAS! The attainment further enhances the ...
GSO Technical Regulations require suppliers of certain goods to go through checks on their products to see if they are “fit” for the Gulf countries’ common market, meaning they are safe to use and of good quality. These check procedures make up the “Conformity Assessment” and require the...
Conformity assessment procedures The conformity assessment procedures forClass Adevices can be carried out, as a general rule, under thesole responsibility of the manufacturersin view of the low level of vulnerability associated with these products; The manufacturers arenot required to obtain manufacturing...