1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

ISO 13485 and ISO 14969 – Medical Devices QMS

ISO 13485 and ISO 14969 – Medical Devices Quality Management System

Page 1 of 6
Sort By:
Title Start Date
Replies Views
Last Message ↓
  1. Mabel Ng

    Reviewer and Approver level

    Mabel Ng, Sep 5, 2024
    Replies:
    2
    Views:
    105
    yodon
    Sep 5, 2024
  2. Agnes N.

    7.5.6 Validation of processes for production and service provision

    Agnes N., Apr 27, 2024
    Replies:
    2
    Views:
    854
    yodon
    Apr 30, 2024
  3. flyonthewall

    CER Cleaning

    flyonthewall, Apr 24, 2024
    Replies:
    1
    Views:
    248
    Andy Nichols
    Apr 24, 2024
  4. Crossi89

    Should NCMR or rejection be part of DHR?

    Crossi89, Apr 18, 2024
    Replies:
    0
    Views:
    208
    Crossi89
    Apr 18, 2024
  5. Eloisa Hufana

    Mobile Scooters Classification

    Eloisa Hufana, Feb 13, 2024
    Replies:
    2
    Views:
    579
    Eloisa Hufana
    Feb 19, 2024
  6. Jeremy B Maher

    ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3

    Jeremy B Maher, Oct 26, 2023
    Replies:
    4
    Views:
    1,038
    Andy Nichols
    Nov 1, 2023
  7. Kishnu Vaarma ROSS

    ISO 13485

    Kishnu Vaarma ROSS, Nov 3, 2022
    Replies:
    3
    Views:
    1,977
    Kishnu Vaarma ROSS
    Nov 14, 2022
  8. yzl1018

    Is there any Brazilian biosafety standard or regulation?

    yzl1018, Dec 18, 2021
    Replies:
    0
    Views:
    1,914
    yzl1018
    Dec 18, 2021
  9. John C. Abnet

    Medical device Non-conformance based on ISO 14971 ?

    John C. Abnet, Nov 30, 2021
    Replies:
    5
    Views:
    912
    John C. Abnet
    Dec 1, 2021
  10. Malius

    Infallibility of QA department?

    Malius, Nov 18, 2021
    Replies:
    10
    Views:
    1,439
    Jennifer Kirley
    Nov 23, 2021
  11. Jimqa

    Best practice in tracking changes in Records

    Jimqa, Nov 15, 2021
    Replies:
    6
    Views:
    682
    Andy Nichols
    Nov 18, 2021
  12. TKOMaine

    Design company not ISO13485 using a Manufacturing company that is ISO13485.

    TKOMaine, Nov 9, 2021
    Replies:
    7
    Views:
    931
    Andy Nichols
    Nov 10, 2021
  13. Ana Silva

    ISO13485: Marketing materials and design files

    Ana Silva, Aug 24, 2021
    Replies:
    3
    Views:
    1,480
    Ana Silva
    Aug 24, 2021
  14. Stephen1985

    Sterilisation of Medical Devices

    Stephen1985, Aug 2, 2021
    Replies:
    1
    Views:
    720
    yodon
    Aug 2, 2021
  15. Kamil

    Clean Room Environments Specifications

    Kamil, Feb 22, 2021
    Replies:
    1
    Views:
    845
    Mary
    Jun 22, 2021
  16. Bahamas

    Looking for a wide Rollator /walker and other recommendations

    Bahamas, Jun 9, 2021
    Replies:
    1
    Views:
    633
    Andy Nichols
    Jun 9, 2021
  17. Francesco.l

    USB-IF standard includes also ISO13485

    Francesco.l, Apr 30, 2021
    Replies:
    1
    Views:
    831
    Andy Nichols
    Apr 30, 2021
  18. HeathW

    Is validation of training tools required?

    HeathW, Mar 26, 2021
    Replies:
    5
    Views:
    994
    HeathW
    Apr 1, 2021
  19. JakobA

    Looking for test people

    JakobA, Mar 2, 2021
    Replies:
    7
    Views:
    782
    JakobA
    Mar 12, 2021
  20. Stephen Lennon

    ISO 13485:2016 clause 8.2.4

    Stephen Lennon, Feb 16, 2021
    Replies:
    3
    Views:
    2,282
    Andy Nichols
    Feb 16, 2021
Showing threads 1 to 20 of 106

Thread Display Options

Loading...
Page 1 of 6