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IEC 62304 - Medical Device Software

IEC 62304 - Medical Device Software - Software Life Cycle Processes

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  1. ConstantChange22

    IEC 62304 for developer tools that are packaged with final product.

    ConstantChange22, Aug 29, 2023
    Replies:
    3
    Views:
    1,967
    yodon
    Aug 30, 2023
  2. ConstantChange22

    Does IEC-62304 suggest that the tools used for configuration management be validated(CSV'd))

    ConstantChange22, Oct 12, 2022
    Replies:
    1
    Views:
    1,818
    yodon
    Oct 12, 2022
  3. Carloz Sanchez

    Unvalidated database with our validated software system?

    Carloz Sanchez, Jun 27, 2022
    Replies:
    4
    Views:
    1,031
    Carloz Sanchez
    Jun 28, 2022
  4. MrTetris

    Traceability in Medical Software Development Process

    MrTetris, Oct 29, 2018
    Replies:
    1
    Views:
    7,519
    yodon
    Jul 21, 2021
  5. Quality Manager Liz

    Certification to BS EN 62304:2006

    Quality Manager Liz, Oct 30, 2017
    Replies:
    4
    Views:
    3,366
    Andy Nichols
    Nov 9, 2017
  6. QAengineer13

    New product Introduction- Software Requirements

    QAengineer13, Oct 1, 2015
    Replies:
    9
    Views:
    3,178
    Naveen Goyal
    Mar 21, 2017
  7. Scott Fine

    Does software testing tool need to be 62304-compliant?

    Scott Fine, Nov 5, 2015
    Replies:
    4
    Views:
    2,446
    yodon
    Nov 16, 2015
Showing threads 1 to 7 of 7

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