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.