ISO 13485 & EU MDR - Expert Advice Community

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  • Rework requirements

    Under what circumstances a medical device which has already been put into service can be returned by the user or patient to the manufacturer to be repaired or modified? Does this trigger any documentation or procedures to be in place? What are the risks?

  • MDR Labelling

    For a company that manufactures textile medical devices having all the required information but the date of manufacture (the expiration date is not applicable) on a woven label which is directly sewn onto the medical device, is it acceptable under the MDR to have the date of manufacture printed on a sticker label which will be placed on the device`s first level of packaging - plastic bag (every device is packaged individually)?  

  • Auditing and creating checklist for medical device labeling

    How to audit and create a checklist for medical device labeling including advertising and claims?

  • Most difficult issue and challenge during initial implementation

    What would be the most difficult issue and challenge during initial implementation?

  • PMS process

    I am new to the PMS process, we have our procedure and plan in place for a class i medical device. Is this template the report that will be submitted for the audit? or this this report tempate just to be used for PMS reviews?

    Also can data be analysed in terms of figures (i,e percentages) or can it be presented in graphical form with appendices?

  • Necessity of MDD and MDR for contract manufacturing companies

    can you shortly explain the necessity of MDD and MDR for contract manufacturing companies which not sell their products to foreign countries but germany only?
  • How a repair under the ISO 13485 can be deemed acceptable?

    i would like to understand how a repair under the iso 13485 can be deemed acceptable for another manufacturers CE marking when the same processes have not been certified by the OEM company

  • Critical non-conformities

    What can I do if critical nonconformities have been detected and my boss wants to continue the production without taking corrective actions?

  • MDR classification

    I want to ask about MDR classification. As there are two categories for active devices
    1. Active therapeutic device
    2.Active device intended for diagnosis and monitoring
    I get confused which one is close to intensive care ventilators?
    and is rule 22 applicable for these devices?

  • New requirements for technical files

    We are working through our documentation with the help of Advisera. I do have questions on the new requirements for technical files. Do you have any samples or templates available?

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