Regulatory Open Forum

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  • 1.  ISO13485 and 21 CFR 820

    Posted 29-May-2013 20:16
    Dear Community,
    I am working for a small start up company that will be manufacturings ASRs. Can you help me understand if it is important to be compliant with ISO 13485 and 21 CFR 820. There are only a few differences between the two. Has anyone  developed a hybrid QSR covering all requirements for both Quality Systems?  We would like to sell our ASRs in the US and EU. Greatly appreciate your insights.

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    Patricia Carrigan PHD
    Scottsdale AZ
    United States
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  • 2.  RE:ISO13485 and 21 CFR 820

    Posted 30-May-2013 08:07
    Although it is theoretically possible to fulfill requirements of European medical device directives using a quality system not registered to ISO 13485, it is usually more straightforward to obtain the registration.  It is not difficult to create a quality system that fulfills requirements of both 21CFR820 (and related regulations such as 803 and 806) and ISO 13485 (and related medical device directive requirements).  You can either start with a structure based on the FDA's 7 subsystems of the QSIT approach and build in the additional ISO requirements, or you can start with the process model of the ISO 13485 approach and build in the additional FDA requirements.  My personal preference is for the latter approach, but I have seen both work well.
    Since the European requirements are currently in the process of changing, you will want to find an ISO Registrar that is also a Notified Body for your type of product.  (And I confess I am completely unfamiliar with European product-specific requirements for ASRs.)  Your Registrar/Notified Body will be able to help you plan ahead so that you are not caught by surprise in the coming changes.
    Good luck.

    Bill

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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    Original Message


  • 3.  RE:ISO13485 and 21 CFR 820

    Posted 30-May-2013 15:08
    I would suggest finding a matrix (the BRC has free one available) that compares the differences between ISO 13485 and 21 CFR 820 (in a lot of areas the requirements are similar) nad build your quality system from there. I have worked for multiple companies where we have developed a quality system that is complaint to multiple regulatory bodies and there requirements. It can be done with some work and proper planning.

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    Keri Froese RAC
    Quality Assurance Specialist
    Ottawa ON
    Canada
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    Original Message


  • 4.  RE:ISO13485 and 21 CFR 820

    Posted 30-May-2013 20:14
    Thank you all for your insights and help. Next question, does the software application that houses all of the documents have to be 21 CFR part 11 compliant? If so does, any one have an off the shelf package that we can customize? Greatly appreciate your help. 

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    Patricia Carrigan PHD
    Scottsdale AZ
    United States
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    Original Message


  • 5.  RE:ISO13485 and 21 CFR 820

    Posted 30-May-2013 20:35
    Technically, the answer is yes.
    However, in the area of medical devices, an investigator is likely to be much more attentive to the requirements of 820.70(i). 
    Although Part 11 is still on the books, one has the impression that the FDA has realized that some of the more abstruse aspects can also be unreasonably expensive.  Here I am speaking about some of the audit trail requirements in particular.  I think the best thing to keep in mind with regard to Part 11 is the reason behind it.  The FDA realizes that without adequate protection it can in some cases be very easy to go back and alter records that exist only electronically.  The FDA wants to be sure that your records are protected:  that they can still be retrieved within the required retention time and that it is impossible, or at least very difficult, for a single person to go back and change a record.  The company should also want a system of electronic records that is secure for business reasons, and not just for compliance. 
    There are several products likely to meet your needs in general.  However, you should first prepare a Software Requirements document that identifies all the features that are important for your company, both now and in the not distant future.  Once you have this document in hand you will be ready to consider your options.
    Bill

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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    Original Message