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 4
Sort By:
Title Start Date
Replies Views
Last Message ↓
  1. AdaTW22

    Is a software platform a medical device???

    AdaTW22, Mar 9, 2020
    Replies:
    1
    Views:
    154
    yodon
    Mar 9, 2020
  2. MIGUEL LUNA

    Inspection KPI's, Who Has Examles and What is Measured?

    MIGUEL LUNA, Jan 28, 2020
    Replies:
    9
    Views:
    338
    MIGUEL LUNA
    Jan 30, 2020
  3. Rotciv

    QMS/DMS for an IT company

    Rotciv, Jan 28, 2020
    Replies:
    2
    Views:
    98
    Rotciv
    Jan 28, 2020
  4. duff999

    Equipment validations

    duff999, Sep 26, 2019
    Replies:
    1
    Views:
    179
    Gözde Aktener
    Jan 27, 2020
  5. Mariah

    "Life Time of a Medical Device"

    Mariah, Dec 9, 2019
    Replies:
    0
    Views:
    320
    Mariah
    Dec 9, 2019
  6. KD Shah

    How to get ISO 13485

    KD Shah, Dec 6, 2019
    Replies:
    2
    Views:
    118
    Andy Nichols
    Dec 7, 2019
  7. Lindy

    ISO 13485:2016 Procedures in China

    Lindy, Nov 4, 2019
    Replies:
    1
    Views:
    208
    Golfman25
    Nov 4, 2019
  8. Airwolf

    CFU count for DI water sample

    Airwolf, Sep 20, 2019
    Replies:
    2
    Views:
    292
    Sam Lazzara
    Oct 4, 2019
  9. Lindy

    3rd Party Supplier Audit in China: ISO 13485 & 21 CFR 820

    Lindy, Apr 17, 2019
    Replies:
    3
    Views:
    734
    Andy Nichols
    Apr 26, 2019
  10. Nikki

    13485:2016 Internal Auditing Online Course?

    Nikki, Mar 8, 2019
    Replies:
    7
    Views:
    638
    Chaitany Thaker
    Apr 15, 2019
  11. Susan7

    Supply for Medical Device - ISO 13485

    Susan7, Mar 21, 2019
    Replies:
    3
    Views:
    351
    tony s
    Mar 22, 2019
  12. Nikki

    Updating QM to 13485:2016 - We do not make medical devices

    Nikki, Sep 25, 2018
    Replies:
    5
    Views:
    736
    tony s
    Mar 22, 2019
  13. Lindy

    Procedure Deviations

    Lindy, Feb 1, 2019
    Replies:
    3
    Views:
    250
    Andy Nichols
    Feb 1, 2019
  14. Lindy

    MDSAP Registrar

    Lindy, Jan 18, 2019
    Replies:
    3
    Views:
    273
    Andy Nichols
    Jan 21, 2019
  15. Neha_Mate

    What is the Medical Device Classification?

    Neha_Mate, Jan 14, 2019
    Replies:
    0
    Views:
    222
    Neha_Mate
    Jan 14, 2019
  16. Greig

    ISO13485 - The correct standard for pharmaceutical packaging?

    Greig, Jul 3, 2018
    Replies:
    7
    Views:
    862
    Greig
    Nov 28, 2018
  17. Renaz

    PFMEA in low volume medical device manufacturing

    Renaz, Oct 20, 2018
    Replies:
    2
    Views:
    344
    John C. Abnet
    Oct 22, 2018
  18. Karly Chester Etzel

    Design and Development Plan

    Karly Chester Etzel, Sep 25, 2018
    Replies:
    4
    Views:
    538
    Karly Chester Etzel
    Oct 9, 2018
  19. Jimbo11

    Preparation For Upcoming External Audit 13485

    Jimbo11, Sep 3, 2018
    Replies:
    3
    Views:
    430
    Andy Nichols
    Sep 4, 2018
  20. Diane Hunt

    Question on One Sentence in 7.1 of ISO 13485:2016

    Diane Hunt, Aug 28, 2018
    Replies:
    4
    Views:
    496
    Diane Hunt
    Aug 29, 2018
Showing threads 1 to 20 of 77

Thread Display Options

Loading...
Page 1 of 4