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FDA registration and ISO 13485 recertification

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Rahul, Jan 5, 2016.

  1. Rahul

    Rahul New Member

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    Hello,
    We recently got FDA registered. We have an upcoming ISO 13485 re certification audit.
    Does the auditor look for FDA compliance while auditing for ISO 13485?
    I guess what i am trying to ask is how different my ISO 13485 recert audit will be since we are FDA registered?
     
  2. Ronen E

    Ronen E Well-Known Member

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    Various clauses in ISO 13485:2003 pose requirements related to identifying and meeting regulatory requirements. FDA requirements are regulatory ones, so your ISO 13485 auditors might look for evidence that you have properly identified applicable FDA requirements and are complying with them. On the other hand, FDA requirements will not be the focus of the audit (unless they resemble ones explicit in ISO 13485).
     
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  3. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    I agree with Ronen, your ISO 13485 audit should not change significantly. Any differences would deal with the specifics. I had a great recall procedure for the USFDA, but I also had shipped product to Canada and their recall process was not covered and the generic "any other foreign government requirements" didn't fly.

    Moving forward with the Single Audit Programs that might not be the case. They may get more into the specifics of your registered government regulations similar to how the FDA would, but that is to be seen as MDSAP rolls out.
     
  4. Ronen E

    Ronen E Well-Known Member

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    In my understanding MDSAP "enhancements" over "baseline" ISO 13485 requirements would apply only when a MDSAP audit/certification is requested / agreed upon upfront, and obviously only if the certifying body is also a MDSAP-qualified body (quite rare at the moment). This might change in the future but we're yet to see if/how MDSAP picks up.
     
  5. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    Agreed. Health Canada is moving to MDSAP as a replacement to CMDCAS by 2017. I did get a finding during a past ISO/CMDCAS assessment for not calling out the Canadian recall process specifically. IMHO I think in the future more country specific requirements will be reviewed under ISO 13485 as MDSAP expands under the guise of meeting "other regulatory and/or governmental", but only time will tell.
     

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