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  1. OrangeIsEnergy
    Post

    Device Removals - FDA notification requirements

    Yeah, that helps. In writing our procedure, what I did is encompassed all requirements of Part 806 and Part 7 in the section outlining what is...
    Post by: OrangeIsEnergy, Feb 24, 2016 in forum: US Medical Device Regulations
  2. OrangeIsEnergy
    Thread

    Device Removals - FDA notification requirements

    I am updating our Procedure on device removals, and in reading 21CFR7 Enforcement Policy and 21CFR806 Medical Devices; Reports of Corrections and...
    Thread by: OrangeIsEnergy, Feb 19, 2016, 2 replies, in forum: US Medical Device Regulations
  3. OrangeIsEnergy
    Post

    Options/suggestions for external training in risk management and design controls

    Also, I just found this company with training options: Center for Professional Innovation and Education...
    Post by: OrangeIsEnergy, Jan 15, 2016 in forum: Training - Internal, External and Web-Based
  4. OrangeIsEnergy
    Post

    Options/suggestions for external training in risk management and design controls

    Just checking in to see if anyone has suggestions... Anyone used Oriel Stat A Matrix for training? It's one I came across during my online...
    Post by: OrangeIsEnergy, Jan 15, 2016 in forum: Training - Internal, External and Web-Based
  5. OrangeIsEnergy
    Post

    Options/suggestions for external training in risk management and design controls

    Can you specify what ones you recommend?
    Post by: OrangeIsEnergy, Jan 11, 2016 in forum: Training - Internal, External and Web-Based
  6. OrangeIsEnergy
    Post

    Options/suggestions for external training in risk management and design controls

    I agree that bringing in a consultant to address the problems head on and learn from them at the same time would be the most solid and timely...
    Post by: OrangeIsEnergy, Jan 11, 2016 in forum: Training - Internal, External and Web-Based
  7. OrangeIsEnergy
    Thread

    Options/suggestions for external training in risk management and design controls

    Hi, My company has an ISO 13485 certified QMS - we manufacture IVD Medical Devices. I am looking to outsource training in the areas of risk...
    Thread by: OrangeIsEnergy, Jan 8, 2016, 9 replies, in forum: Training - Internal, External and Web-Based
  8. OrangeIsEnergy
    Post

    CMDCAS addition to ISO 13485

    No worries! thank you!
    Post by: OrangeIsEnergy, Aug 25, 2015 in forum: Canada Medical Device Regulations
  9. OrangeIsEnergy
    Post

    Connecting Complaints and Risk Analysis

    We use QT9 Quality Management software for ISO 13485. It has modules for all aspects of ISO 13485 compliance (all sold as one package, not...
    Post by: OrangeIsEnergy, Aug 24, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  10. OrangeIsEnergy
    Post

    CMDCAS addition to ISO 13485

    Yes! That would be wonderful! I need to present a timeline for updating our system for CMDCAS, so any info on the changes needed is helpful. I...
    Post by: OrangeIsEnergy, Aug 18, 2015 in forum: Canada Medical Device Regulations
  11. OrangeIsEnergy
    Thread

    CMDCAS addition to ISO 13485

    Hi all, Does anyone have a summary or comparison of ISO 13485 and what is required by the CMDCAS addition? My company is looking into licensing...
    Thread by: OrangeIsEnergy, Aug 14, 2015, 5 replies, in forum: Canada Medical Device Regulations
  12. OrangeIsEnergy
    Post

    Document & record retention times

    Thank you all for the helpful input. Since we make in vitro diagnostics, with minimal risk to users, and the longest shelf life is 2 years, I...
    Post by: OrangeIsEnergy, Aug 13, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  13. OrangeIsEnergy
    Post

    Document & record retention times

    Just trying to save on time to do this with historical records. We now scan them all in, but for the past 5 years we didn't. And I still need to...
    Post by: OrangeIsEnergy, Aug 12, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  14. OrangeIsEnergy
    Post

    Document & record retention times

    Even the non-product related records such as corrective action reports, internal audits, etc.? These are not related directly to a batch or lot...
    Post by: OrangeIsEnergy, Aug 12, 2015 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  15. OrangeIsEnergy
    Thread

    Document & record retention times

    Hello, I am looking for some industry standard guidance on retention time for ISO 13485 certified systems. We manufacture single use IVDDs for...
    Thread by: OrangeIsEnergy, Aug 10, 2015, 10 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
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