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  1. Jo Campbell
    Thread

    EtO Sterilisation of Syringes

    Hi All, Whilst looking at a packaged syringe that had been sterilised using EtO a question came to mind. How is it possible for the Ethylene...
    Thread by: Jo Campbell, Apr 29, 2016, 1 replies, in forum: EU Medical Device Regulations
  2. Jo Campbell
    Post

    Full Sterilisation Validation for Novel Devices

    Thank you Chris, but I have a copy of AAMI TIR 28 and can't find anything that states you need to perform a full EtO sterilisation validation for...
    Post by: Jo Campbell, Feb 12, 2016 in forum: US Medical Device Regulations
  3. Jo Campbell
    Thread

    Full Sterilisation Validation for Novel Devices

    Hi All, In relation to FDA requirements, where in any regulations or standards does it state that for novel products you must perform a full...
    Thread by: Jo Campbell, Feb 10, 2016, 2 replies, in forum: US Medical Device Regulations
  4. Jo Campbell
    Post

    IFU and Label translations

    Thank you Chris, that is my thinking too. JoCam
    Post by: Jo Campbell, Jan 18, 2016 in forum: Other Medical Device Regulations World-Wide
  5. Jo Campbell
    Thread

    IFU and Label translations

    Hi All, Is it acceptable to include on labelling and IFU's languages of territories that a medical device is not yet registered in? Regards, JoCam
    Thread by: Jo Campbell, Jan 18, 2016, 3 replies, in forum: Other Medical Device Regulations World-Wide
  6. Jo Campbell
    Post

    Extension to Scope

    Thank you Ronen, that will certainly make things easier.
    Post by: Jo Campbell, Jan 15, 2016 in forum: EU Medical Device Regulations
  7. Jo Campbell
    Thread

    Extension to Scope

    Hi All, We are designing a new device based on the technology of our existing device. The existing device consists of hardware and a consumable,...
    Thread by: Jo Campbell, Jan 14, 2016, 2 replies, in forum: EU Medical Device Regulations
  8. Jo Campbell
    Thread

    EtO Sterilisation Validation

    Hi All, We manufacture a device used in laporoscopic surgery which is sterilised by EtO. For the validation of the EtO sterilisation we chose...
    Thread by: Jo Campbell, Jan 5, 2016, 1 replies, in forum: Medical Devices (21 CFR Part 820)
  9. Jo Campbell
    Post

    Basic question on controlling a Quality Policy

    I enter the distribution details of the controlled documents onto my Document Master List, and circulate up-issues to these recipients as a part...
    Post by: Jo Campbell, Jan 4, 2016 in forum: ISO 9001:2008 - Quality Management Systems
  10. Jo Campbell
    Post

    Basic question on controlling a Quality Policy

    Hi Patts, If you wish to extract the Quality Policy from the Quality Manual for display purposes you can add a statement to the footer that goes...
    Post by: Jo Campbell, Dec 17, 2015 in forum: ISO 9001:2008 - Quality Management Systems
  11. Jo Campbell
    Post

    ETO Sterilisation

    Thank you Vintage Goose, We only have the one item requiring sterilisation, so don't have any other validated loads to compare against.
    Post by: Jo Campbell, Nov 23, 2015 in forum: EU Medical Device Regulations
  12. Jo Campbell
    Thread

    ETO Sterilisation

    Hi All, We include a paper IFU booklet in our consumable packs for sterilisation by ETO. If we were to add another language to the IFU,...
    Thread by: Jo Campbell, Nov 13, 2015, 2 replies, in forum: EU Medical Device Regulations
  13. Jo Campbell
    Post

    Additional Notified Body

    Thank you for your reply. I feel that we should stick with the existing Notified Body as I'm also aware that all are under pressure at the...
    Post by: Jo Campbell, Oct 20, 2015 in forum: EU Medical Device Regulations
  14. Jo Campbell
    Thread

    Additional Notified Body

    Hi All, We are certified to ISO 13485 and ISO 9001, and our product has the CE approval. We are just about to submit a Technical File for a new...
    Thread by: Jo Campbell, Oct 15, 2015, 6 replies, in forum: EU Medical Device Regulations
  15. Jo Campbell
    Post

    Company name change and product labelling

    Thank you Rich008. Our licence is in the new name, it's our product that isn't. I'm guessing that we will have to re-label all the stock...
    Post by: Jo Campbell, Oct 13, 2015 in forum: EU Medical Device Regulations
  16. Jo Campbell
    Thread

    Company name change and product labelling

    Hi All, We have recently undergone the painful process of changing our company name, and as a result now have a warehouse full of stock labelled...
    Thread by: Jo Campbell, Oct 9, 2015, 2 replies, in forum: EU Medical Device Regulations
  17. Jo Campbell
    Post

    Changing the classification of a medical device

    Thank you Jon, I'm sure I can get enough information together to support the lower classification, especially as HealthCanada and PMDA are of...
    Post by: Jo Campbell, Oct 6, 2015 in forum: EU Medical Device Regulations
  18. Jo Campbell
    Post

    Changing the classification of a medical device

    Hi Jon, Thank you for your reply. I joined the company just after the device had received CE mark, and it had been classified under Annex IX...
    Post by: Jo Campbell, Oct 5, 2015 in forum: EU Medical Device Regulations
  19. Jo Campbell
    Post

    Changing the classification of a medical device

    Hi Somashekar, Some countries will register a medical device for sale on the strength of the CE mark alone, and this is always easier when the...
    Post by: Jo Campbell, Oct 5, 2015 in forum: EU Medical Device Regulations
  20. Jo Campbell
    Thread

    Changing the classification of a medical device

    Hi All, We manufacture a novel medical device that has achieved the CE mark in Europe classified as a IIb. However, whilst submitting this...
    Thread by: Jo Campbell, Oct 5, 2015, 8 replies, in forum: EU Medical Device Regulations
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