Hi Friends,

I’m new to medical devices stream.Can any one help me out in clarification of these doubts

  We had performed crimping validation for stent systems in new m/c.   While checking for inflation of stents it was observed some stents alone showed dog bone effect while remaining d'nt .

 My doubts
1) Definition for dog bone effect and scientific rationale behind this effect .
2) If this effect is not observed whether the stent is considered to be  
3) Whether we can justify this effect with the % expansion of stent. if so  
4) How can we classify the effect - Critical with Quality Impact or Critical 
    with Non-quality impact.
5) What parameters should be covered during compiling the report and is 
    there any criteria like how many trials can be done for validation.
6) Is any guidelines available for reference for explaining the quality  
    parameters of medical devices like pharmaceuticals .