iso 13485:2016

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    Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820

    I am taking over the QA/RA Management Representative role for my company and looking for some classes and/or online training for FDA and ISO 13485. We have a couple Class 2 medical devices(Dental Imaging Software & IntraOral X-Ray Sensors) and two Class 1 medical devices (IntraOral Camera &...
  2. T

    RISK: Selling Diagnostic Devices on Amazon

    HELP/ADVICE PLEASE I have once again been asked by our CEO about selling our trademarked Class I and Class II biologic culture/diagnostic devices on Amazon. Our marketing director is convinced that we need to be in this arena... The idea of using Amazon makes me VERY nervous as some of our...
  3. S

    PPT for ISO13485:2016 Employee Training (Request)

    Dear All., It is a request that kindly share PPT for ISO13485:2016 for training purpose. Thanks in advance:thanx:
  4. S

    Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness

    I was recently given a noncompliance against ISO 13485: 2016, clause 6.2 Human resources because of the NOTE " The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided." I am a contract converter...
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    Defining Approvals Required for Design Control Documents

    Associates, I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types. I know there's some flexibility in who the organization identifies as required signatories on documents per...
  6. M

    Multiple missed POs grounds for SCAR?

    Hypothetically speaking, if a supplier repeatedly doesn't fulfill a PO, either wholly or partly, is that grounds for a SCAR? The product that DOES ship is good (i.e., meets all product specifications) so it's not a product issue, and from what I've found, ISO 13485:2016 doesn't speak to process...
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    ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control

    Hello All, So the new requirement in section 7.5.2(c) says that I should have requirements for cleanliness of product or contamination control if "product cannot be cleaned prior to sterilization or it's use, and cleanliness is of significance in use". Do my current requirements for product to...
  8. M

    Medical Device Traceability

    Hello all. As a contract manufacturer of an "implantable finished medical devices" that are returned in bulk to the client for sterilization, final packaging, labeling, distribution, sale, etc., to what extent to we have to implement ISO 13485:2016 Section Is the client the only...
  9. R

    ISO13485/ISO9001 Convenient Document Management System

    Hello everyone, I plan our future Doc Management System, we are working in electronics for industrial equipment and also plan to extend our business to Medical Device (we are a small company <20 persons). So our DMS must be ISO 9001 & ISO 13485 compliant ;) During previous experiences in Medical...
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    Effective Date on Documents

    All, Please correct me if I'm wrong - within 21 CFR 820, ISO 13485:2016, and the MDD, I cannot find that having the effective date on a document is required. All that is required is that the document was reviewed and approved, has an identifier (e.g. name, number, revision level, etc.)...
  11. xfngrs

    How similar or different are IATF 16949 Vs. ISO 13485

    Has anyone worked in or is familiar with both the automotive and the medical quality management systems? I am familiar with the automotive and am wondering how similar or different they are? Also who has to be certified to the medical standard? And are there government standards you would...
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    Essential requirements checklist needed?

    Hello, We had the first day of our ISO 13485:2016 audit today. Our business is a very small company who primarily assembles IVD's for self test use under contract from the manufacturer from CE marked components. This is not OBL, the manufacturer is named as such on the products and IFU. The...
  13. S

    GM/VP softgrading internal audit finding - need feedback from an audit guru!

    Hello, I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and...
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    Software validation (4.1.6 ISO 13485:2016)

    Hi everyone, In our company we have an ERP for finance activities and to record some data concerning inventories of our products (stock, lot number, expiration date...). However, all datas are paper based first. We enter these datas only in a second time in the ERP. Do you think that we...
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    Transport validation to different climate zones

    Hello! I am not sure, that this is the right forum (13485...), but maybe you can give me some directions. I wonder what test protocol I should use to validate our medical devices for shipping to all countries around the world. I found the information, that ICH has classified four (five)...
  16. J

    Supplier controls for consumer-grade off-the-shelf products

    Hello - I'm currently working on supplier evaluation and qualification for a medical device software company. All supplied products are off-the-shelf and/or available to the general public, such as cloud and web services, PC hardware, etc. Am I required to monitor such suppliers (e.g. Dell...
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    Does anybody have quiz's available? ISO 13485:2016 Training Material

    Hello, I am training for an exam in September. ISO 13485:2016 & 14971:2012. Does anybody have quiz's available or exam training material (legal of course)? Thanks!
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    ISO 13485:2016 and regulatory requirements - Contract Manufacturing

    Hi, We are a contract manufacture who are currently iso 13485:2003. Our transition to 2016 is in September. Although 13485 we do not manufacture any medical devices. I have listed all regulatory elements within the standard as N/A within our manual as we do not work to any reg requirements...
  19. J

    Change Control - Minimum Requirements and Unhappy Staff

    Good Morning I'm currently in the middle of a very difficult situation I would greatly appreciate some guidance on. I work for a small but growing Medical Device company, we hold both 9001 and 13485 certifications. I started here December last year and have been updating their quality...
  20. pbojsen

    Intuitive Quality Design and Documentation Systems

    We're trying out "intuitive quality design" and it's having an effect, as expected, on our documentation. While before we had most of the information in the high level QS SOP, (e.g. Design Controls), that information is now being pushed down into the lower level documents at "point of use,"...
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