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  • QMS training

    Hi, I'm having some doubts on ISO 13485, is it necessary to have QMS training once in 6 months, as per the standard?

  • ISO 13485:2016 vs 13485:2012

    How to identify the new requirements of ISO 13485:2016 vs 13485:2012

  • ISO 13485 and Staff morale

    How can ISO 13485 support and improve Staff morale?

  • Product complaints

    Is there a deadline for handling product complaints?

  • Mould validation

    How important is the mould validation documents?

  • Conformance with ISO 13485

    Does 21 CFR 820 requires conformance with ISO 13485?

  • First qualified person

    Qualification procedures need to be developed and implemented for a test or a certain manufacturing procedure. A test, OJT or validation should be included. However, who can be the "first" qualified person? For the validation of the qualification, there needs to be a person to compare. We are in the process of first developing the qualification procedure. Do we need to establish a procedure that specifies the first person to be qualified? Or can anyone or someone who had been doing the job become a first qualified person?

  • Complaint handling and vigilance reporting

    Pl. enlighten me on the following: How and where to include the determination of vigilance reporting in the customer complaint procedure or process
  • Transition to ISO 13485:2016

    We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?

  • Effectiveness of QMS and Product Recall

    1. How can you measure the effectiveness of QMS? 2. Do every product recall will require an advisory notice? Is there any advisory notice which will not required a product recall?
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