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  1. JCIC49
    Post

    Revision of the MDD

    As an update the ENVI committee are meeting tomorrow to approve what is expected to be the final versions of t he MDR and IVD regulations. Below...
    Post by: JCIC49, Jun 14, 2016 in forum: EU Medical Device Regulations
  2. JCIC49
    Post

    A question for all you consultants and contractors out there.

    As an update, I have taken a new full time roll following redundancy. Contracting and consultancy will have to wait.
    Post by: JCIC49, May 27, 2016 in forum: Job Openings and Employment Opportunities
  3. JCIC49
    Post

    A question for all you consultants and contractors out there.

    Can I thank you all for your replies, they has been included in the thoughts and considerations I have about the next steps I will be taking. Jon
    Post by: JCIC49, Apr 25, 2016 in forum: Job Openings and Employment Opportunities
  4. JCIC49
    Thread

    A question for all you consultants and contractors out there.

    I have a question, request for advice any thoughts you might have. I am in the position where I am being made redundant and I am now looking for...
    Thread by: JCIC49, Apr 22, 2016, 6 replies, in forum: Job Openings and Employment Opportunities
  5. JCIC49
    Post

    Authorised rep question

    The first question I have is if the medical device has a CE mark , they must have an Authorised Representative. If you are outside of the EU you...
    Post by: JCIC49, Jan 29, 2016 in forum: EU Medical Device Regulations
  6. JCIC49
    Post

    ISO 13485 - New Facility Question

    The simple answer to your question is yes. The requirements are covered in ISO 13485 clause 7.3 Design and Development. This should already be...
    Post by: JCIC49, Jan 28, 2016 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  7. JCIC49
    Post

    Notified Body Debacle

    You don't need to have your ISO 13485 certification with the same notified body who provided the MDD certification. I know of several companies...
    Post by: JCIC49, Jan 26, 2016 in forum: EU Medical Device Regulations
  8. JCIC49
    Post

    Supplier Surveys - Waste or warranted

    The comments raised are all very interesting and sound similar to what I have seen and what I have done When I joined my current company they...
    Post by: JCIC49, Dec 11, 2015 in forum: Other Quality and Business Related Topics
  9. JCIC49
    Post

    Use of Sharepoint for controlling documents

    Matt Thanks for the feedback. Jon
    Post by: JCIC49, Dec 1, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  10. JCIC49
    Post

    Use of Sharepoint for controlling documents

    Thanks for the feedback With regards to the cost of set up etc. This is not an issue as the company is already using it for other activities,...
    Post by: JCIC49, Nov 30, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  11. JCIC49
    Thread

    Use of Sharepoint for controlling documents

    I can remember that there were threads about this on the Cove, but I cannot remember the details. I am interested in peoples thoughts on this...
    Thread by: JCIC49, Nov 27, 2015, 6 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  12. JCIC49
    Post

    Sick of Being Disrespected by Coworker - Meeting Monday - Need Advice

    Nikki I agree with everything that Claes has said, I have been through a similar experience myself. The important thing is to respect yourself...
    Post by: JCIC49, Nov 20, 2015 in forum: Coffee Break and Community Discussion Forum
  13. JCIC49
    Post

    ISO 13485 Revision

    I think we have got 2 issues mixed up here, I was talking about retrospective validation of software used in the manufacturing process on in...
    Post by: JCIC49, Nov 12, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  14. JCIC49
    Post

    ISO 13485 Revision

    Hi Marcelo, Thanks for the clarification, as I new device software was covered by IEC 62304 and I thought I had missed something. Do you have...
    Post by: JCIC49, Nov 11, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  15. JCIC49
    Post

    ISO 13485 Revision

    Marcelo, Thanks for the information. A question in relation to ISO TR 80002-2, is it going to cover software used to support the QMS and in...
    Post by: JCIC49, Nov 11, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  16. JCIC49
    Post

    ISO 13485 Revision

    Hi Steve, It does raise some questions. I agree that standard MS Office packages won't require validation, unless as you say they have macros or...
    Post by: JCIC49, Nov 10, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  17. JCIC49
    Post

    ISO 13485 Revision

    Hi Steve, I have done exactly the same on usability on our technical files. I just mentioned it as this seems to be one of the new areas that is...
    Post by: JCIC49, Nov 10, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  18. JCIC49
    Post

    ISO 13485 Revision

    Hi Steve, I have done the same and I am still currently reviewing it. it would be good to share your thoughts abut what is in it and the impact...
    Post by: JCIC49, Nov 10, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  19. JCIC49
    Post

    ISO 13485 Revision

    Marcelo, Thanks for the feedback the January and April dates are what I had heard but I wasn't sure if this was correct. Jon
    Post by: JCIC49, Oct 21, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  20. JCIC49
    Post

    ISO 13485 Revision

    Thanks for the update, I look forward to it being published. Does any one know if it has changed much from the version published in February? I...
    Post by: JCIC49, Oct 21, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
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