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Servicing requirements ,Service Life and Complaint processing

  • 1.  Servicing requirements ,Service Life and Complaint processing

    Posted 01-Aug-2019 07:28
    Hi,
     
    Are there specific product specific (especially lasers) servicing requirements for USA/ EU/Japan/Brazil/Canada ? Is  there a minimum frequency for preventive maintenance ?
     
    Is there a minimum service life that the device manufacturers need to provide ? Can the service life be reduced ? Again for the above markets .
     
    Currently we continue to repair / supply spare parts for devices which have exceeded more than twice the service life wherever possible. However if the management has decided against the servicing after the service life , then are the manufacturers expected to process complaints for such devices? I could understand adverse event reporting would be required however what about the non-reportable ones ?
     
    Any guidance on these topics will be extremely helpful.
     
    Thanks & Regards,
     
    Rashmi Pillay
    Regulatory Affairs Associate

    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
     
    T + 61 8 7074 8105
    E  rpillay@ellex.com
    W ellex.com
    .............................................................................
     
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