I work for a medical device manufacture that brings in 80% finished product that is custom fit to clients. We do the final assembly and this "Custom" work. Some of this work is routine (make a piece 2" shorter) some does involve custom bending of sheet stock and welding. I can't possibly cover every adaptaion in the MDR. I do cover every adaptation in the DHR. I'm not sure this is enough to satisfy validation for this change. Any comments on this will be very helpful.
As far as what needs to be changed think of someone with partial use of their right hand. Some people can use 2 fingers some 3 and so on, we have to accomodate all of these but can not anticipate or test every iteration.
Thanks
As far as what needs to be changed think of someone with partial use of their right hand. Some people can use 2 fingers some 3 and so on, we have to accomodate all of these but can not anticipate or test every iteration.
Thanks

Who approves and gives certifications under ISO or QS then??