Get a FREE ISO 13485 Internal Auditor exam worth $649
with your ISO 13485 toolkit purchase
Limited-time offer – ends September 26, 2024
Save with the bundle

ISO 13485 & EU MDR - Expert Advice Community

Home / ISO 13485 & EU MDR

Discussions

Top Contributors

Expert

Rhand Leal

4151
Discussions
Expert

Carlos Pereira da Cruz

1915
Discussions
Expert

Dejan Kosutic

365
Discussions

Most Popular Tags

Product: Conformio Product: ISO 27001 Documentation Toolkit Product: ISO 13485 & MDR Integrated Documentation Toolkit ISO 27001 ISO 9001 Risk Assessment Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit Product: ISO 13485 Documentation Toolkit ISMS Internal Audit register of requirements Product: ISO 27001/Risk Assessment Table Product: ISO 27001 & ISO 27017 & ISO 27018 Cloud Documentation Toolkit ISO27001 Product: ISO 27001 Internal Auditor Course
Select
CREATE NEW TOPIC +
Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • Question about data storage

    I am following some courses on medical devices'ISOs on Advisera and I have been given this email to ask a particular question. I was wondering about the storage of data during lab experiments prior FDA/CE mark. We record everything on an electronic lab journal (protocol, procedures and conclusions) but I was wondering whether the raw date should also be embedded into the eLN or it is enough to refer to the documents containing data (sometimes big data) in order to be FDA/CE compliant. Thank you very much in advance

  • Expanding and elaborating scope

    My question is 1- I am going to Update the medical device file as per Eumdr (Article 1) so what should be the scope? As per my understanding, I have defined the scope for PACS This procedure applies to: Technical/engineering documentation required for the release of XYZ medical device software. Changes to the product, process, facility, quality system, or organization. All countries and territories where XYZ medical devices are approved for sale (EU for CE Marking) Just want to confirm is this sufficient scope or should expand our scope or if you suggest some more. 2- What is the new changes as per new ISO 15223-1:2021 for PACS software 3- Is there any specific retention time period for software? As per MDR 10 years after the last device covered by EU DOC & for implantable for 15 years.

  • Lateral flow device

    i am trying to find out what a lateral flow device using saliva would come under with the FDA class 1 or class 2

  • Calling organization's products after certified ISO 13485 QMS in place

    With a certified ISO 13485 QMS in place  which is in alignment to national regulatory body as well (though not audited by national regulatory body), can an organization call its products:
    1. GMP grade products or
    2. ISO13485 conforming products or
    3. ISO 13485 and GMP conforming products
    Note: I have not used the word compliant for GMP since as I understand that the organization needs to be audited by regulatory body to claim the same?

  • Risk Management and FMEA

    I am working on completion of our Risk Management Procedures. Is FMEA required for Class I devices, or is there a simpler alternative we can use?  

  • Examples of Applicable regulatory requirements

    What are examples of Applicable regulatory requirements?

  • Does ISO 13485 cover code required electrical and fire approval such as UL?

    Does ISO 13485 cover code required electrical and fire approval such as UL or is this just medical approval?

  • ISO 13485 / MDR

    1. Clinical evaluation - are we qualified to complete this ourselves? I have documented professional experience of >14 years but not a medical degree 2. MDR requires a suitably qualified person to act as the person responsible for regulatory affairs - is there any definition about what suitably qualified means?

  • Technical file and clinical evaluation

    With the combined package for ISO 13485 and MDR, do we need any external assistance with the technical file and clinical evaluation? i.e. a healthcare professional

  • Language requirements on medical device class 1 products

    1. What language requirements are there on the following in countries within EU?
    • Labels of main product
    • Labels of product boxes
    • Labels of outer boxes
    • Manuals/IFU
    2. Do you have a list on specific language requirements PER country on the above?
Page 19 of 66 pages