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ISO 13485 & EU MDR - Expert Advice Community

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  • Stage 2 audit requirements

    We have a Stage 2 audit scheduled for March. The scope of our certification is the control of manufacture as we are intending to outsource all manufacturing. We don't yet have the manufacturers onboard and are arranging Quality Agreements with them now.

  • Is European certification equal to ISO 13485 ?

    I have a question about ISO standard adaptation for the European company.

  • Establish QMS compliance to ISO 13485 as a reagent manufacturer

    We would like to establish QMS compliance to ISO 13485 in anticipation of business with IVD company wherein our reagent would be a part of their IVD kit. (We will not be involved in the manufacturing of any IVD per se) How would clauses which are specific to a medical device like medical device file, advisory notice, risk analysis, complaint handling etc as per ISO 14971 be applicable for us?

  • Certifying a family of products under ISO13485 when company is ISO 9001 compliant

    Hello, Currently we are certified under ISO9001:2015, however in the next months we pretend to certify a family of products under ISO13485.

  • What else do I need to be ISO 13485 certified when I am ISO 9001 certified?

    I am not currently ISO 13485 certified but 9001:2015 certified. What do I need to be also 13485 certified?

  • ISO 13485 for small companies

    It's regarding the standards fit into an organization with only 2 employees. We develop software for medical image management and (as it seems) need to get a 13485 compliant QMS in order to re-register our products according to MDR. The standard seems to be more geared towards larger organizations (talking a lot about management, CEO, CMO etc..)

  • Reporting of AE to FDA

    We currently have a question we are unable to find an answer to. Scenario: A box contains 200 individually wrapped products. Each individually wrapped product seems to have a loose fray that is visible to the customer. Event = "Loose fray on Product A package." One Event, One product, 200 qty. Our question is as follows: Do we report 200 individual reports, or do we report 1 report specifying that 200 products were associated with the event?

  • Deviation from requirements for batch identification

    I was wondering if you can tell me about the categorization of a finding regarding batch identification

  • Definition for critical suppliers in the context of ISO 13485

    Hi, I am trying to find a definition for a critical part (to determine critical suppliers) in the context of iso 13485.

  • CE mark and ISO 13485 for medical device in EU

    Is it necessary to be ISO 13485:2016 certified before pursuing the CE Marking? Or is having the ISO 13485 more of a benefit, and not a requirement.
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