Medical device reliability process

[i=s] 本帖最后由 wf2002 于 2017-5-15 21:19 编辑 [/i]

从别的行业进这个医疗器械行业快一年了,就可靠度方面的活动做个的小结:
concept phase: Reliability Plan;Reliability risk analysis,
Feasibility phase: Reliability modeling & prediction ,update reliability risk analysis,goal setting
update the reliability plan if needed
Development phase: Prepare reliability test protocols, execute the relevant test; update the reliability prediction;reliability assessment;
update reliability risk analysis if needed
Qualification:delivery all relevant report, summary the result to RA for registeration。update reliability risk analysis if needed。
Then launch for money.

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可靠性技术新手提问

请教下,按钮或者USB口的寿命测试怎么定义测试次数的,有相关规定吗?

2017-5-14 17:56:20

可靠性技术可靠性试验

可靠性新人求指点

2017-5-16 9:01:53

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