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  • 1.  complaint -spare part

    Posted 23-Jun-2018 05:45

    Hi,

     

    An alleged deficiency of a spare part , is that also a complaint ?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

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    E  rpillay@ellex.com

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  • 2.  RE: complaint -spare part

    Posted 24-Jun-2018 11:20
    For the USA FDA, a complaint is written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. The ISO 13485 definition is very similar.

    A medical device is defined within the Food Drug & Cosmetic Act as "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States ...

    Using the above definitions, I would say an alleged deficiency against a spare part is a complaint.

    Sincerely,

    John Beasley, RAC (US)
    Founding Member and Senior Consultant
    MedTech Review, LLC
    www.medtechreview.com
    www.linkedin.com/in/medtechreview





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    Original Message


  • 3.  RE: complaint -spare part

    Posted 25-Jun-2018 06:07
    John has the great answer haha, my answer would be yes.  If the spare part or component is part of the overall listed medical device, then it would also be part of the complaint process.

    ------------------------------
    Richard Vincins RAC
    Vice President Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: complaint -spare part

    Posted 25-Jun-2018 13:23
    John has a great regulatory/quality answer. You can stop there if you want. However, I'd like you to think of 2 other perspectives:

    1. Engineering-wise, if there was a spare part issue, why wouldn't you want to investigate it? It could be a symptom of a larger problem (e.g. supplier change in process, design or manufacturing change that affected the rest of the new lots, etc.).
    2. Here's another point of view: Call it complaint, call it CAPA, or call it plain old customer service, the customer has a problem, and if I were the sales person, I would want answers to give my loyal customer. At the very least prevent this customer from thinking our company doesn't care and spread that word around to other potential customers.

    Hope that helps,

    ------------------------------
    Clarisa Tate
    VP, Product Development and Regulatory Affairs
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
    ------------------------------

    Original Message


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