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  • 1.  Quality management systems

    This message was posted by a user wishing to remain anonymous
    Posted 03-Oct-2017 09:06
    This message was posted by a user wishing to remain anonymous

    ​​If a medical device manufacturer intends to manufacture a non-medical device , what quality systems does he need to comply with? Is compliance to ISO 13485 sufficient ? Or is it essential to comply with ISO 9001 additionally ? Also are there any exemptions if  the non medical device is a Class I?

    Thanks,


  • 2.  RE: Quality management systems

    Posted 04-Oct-2017 08:44
    It is a strategic choice for an organization to meet the requirements of a quality management system. This should be an input to your organization's management and they should decide. Both ISO 9001 and ISO 13485 are quality management system standards and as such provide supporting systems for product realization.

    As outlined in the scope of ISO 13485, there is an exemption of requirements in clause 7.3 for those medical devices that are exempt from the associated regulatory requirements.

    In general, if your organization has a current certification to ISO 13485, you can choose to also implement the concepts of ISO 9001 and not have any problems nor create much additional burden. Then, as the business develops, you can determine any need to also certify to ISO 9001. Please message if you have additional questions.

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
    Becker MN
    United States
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    Original Message


  • 3.  RE: Quality management systems

    Posted 04-Oct-2017 08:45
    It depends on what the non-medical device is and where it will be marketed. I assume that the manufacturer is already operating in compliance with the medical device regs, which would mean that they have a QMS in place already. They will need to identify the requirements that apply to the non-medical device, perform a gap analysis, identify any changes to their operations that will occur when they start producing the non-medical device, and implement policies and procedures as necessary. They need to ensure that (1) they bring themselves into compliance with the requirements around the non-medical device and (2) they remain in compliance with the medical device regulations.

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    Michael Hellerstein
    GeoVax, Inc.
    Smyrna GA
    United States
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    Original Message


  • 4.  RE: Quality management systems

    This message was posted by a user wishing to remain anonymous
    Posted 04-Oct-2017 12:48
    This message was posted by a user wishing to remain anonymous

    ​I do not understand the question. If a manufacturer makes non-medical devices, an organization issuing the ISO 13485 will not cover it as part of the scope as ISO 13485 is limited to Medical Devices. If a manufacturer makes components and other products that fall under the non medical category, manufacturer should consider if there are other industry specific standards or a general standard such as 9001. Remember, standards are voluntary. ISO 13485 is not limited to class of devices.
    Original Message


  • 5.  RE: Quality management systems

    Posted 04-Oct-2017 15:39
    I am a bit confused as to the question. Of course it is possible to make "non-medical devices" such as lab equipment, at a medical device manufacturer. Generally though, your ISO 13485 certificate won't apply, as it is scoped to medical devices. Similarly, I don't see how such non-medical devices can be "Class 1" when those classifications are part of the US and/or EU device regulations, and as such don't apply to medical devices.

    It depends on your customers and the type of product whether a QS certificate like ISO 9000 is required. If it is, you will need to work with a certification group to get that certification and scope. However, in some cases it may not be. However, because you don't really want to confuse your employees by saying "sometimes our quality system applies and sometimes it doesn't," I'd suggest writing some kind of SOP for "design and development (and manufacturing if it applies) of non-medical devices" and spell out exactly what procedures you do expect to be followed.

    g-

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    Ginger Glaser RAC
    Vice-President, Engineering
    MN
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    Original Message


  • 6.  RE: Quality management systems

    Posted 06-Oct-2017 19:33
    ​Regardless of any device you are making, you need to comply to your quality system regardless which one you have QSR, EN ISO 13485 or ISO 9001.

    Regarding class I devices and the requirements of the new European MDR you need to have a QMS in place with respect to EN 13485:2016.

    You also need to understand that devices in Europe are regulated with Directive and or regulation and you need to comply with them before you  affix the CE Mark.

    Common non medical device directives are the WEEE, RoHS and LVD.

    Best,

    Armin

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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armingbeck@aol.com
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    Original Message


  • 7.  RE: Quality management systems

    Posted 07-Oct-2017 10:51

    I agree to some of the previous responses, but in case additional clarification could help, here are my recommendations:

    First, you need to know where you intend to market the product. If you plan to market in the US, whether you comply with ISO 9001/13485 or not does not matter. This will matter if you plan to market your product in other jurisdictions, mainly Europe to get the CE mark.

    Second you need to determine and confirm whether the product is a medical device or not. For the US, in general you need to meet the 21 CFR 820 Quality System Regulations (QSR) if your product is a medical device, enforced by the FDA. If you plan to market the product in other jurisdictions, mainly Europe for the CE mark, the ISO 13485 will be required if the product is a medical device. The ISO 13485 includes the entire ISO 9001 standard with additional requirements. If your product is not a medical device, the ISO 9001 may be sufficient depending on the industry.

    Third, if it is confirmed that the product is a medical device, you need to determine its classification. Depending on the classification, the regulatory burden could be higher or lower. Specifically, if it is a class 1 device, certain sections of the QSR could be exempt if you plan to market the product in the US.



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    Viky Verna, MS BME, MS Pharm, RAC (Global)
    Senior Consultant
    Confinis AG
    Washington DC/United States
    Bern/Switzerland
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    Original Message


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