Critical Suppliers:关键供应商：
For the purposes of MDSAP, “critical suppliers” include, but are not limited to:
在医疗器械单一审核程序（MDSAP）中，“关键供应商” 包括但不限于：
- those entities that supply the organisation with finished devices, i.e., a device, or accessory to any device, that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized,
- suppliers of products, including services, that impact design outputs that are essential for the proper functioning of the device; and
其产品（包括服务）会影响设计输出 —— 而这些设计输出对器械的正常功能至关重要 —— 的供应商。
- suppliers of products and services that require process validation.
需要进行过程确认的产品和服务的供应商。
