PLM Knowledge Base

Tag: medical-devices

9 items with this tag.

  • Apr 25, 2026

    ISO 14971 (Medical Device Risk Management)

    • standard
    • iso
    • risk-management
    • medical-devices
    • regulated
  • Apr 25, 2026

    Design Controls

    • capability
    • design-controls
    • medical-devices
    • regulated
  • Apr 25, 2026

    Design History File (DHF)

    • data-object
    • dhf
    • medical-devices
    • regulated
  • Apr 25, 2026

    Device History Record (DHR)

    • data-object
    • dhr
    • medical-devices
    • as-built
    • regulated
  • Apr 25, 2026

    Device Master Record (DMR)

    • data-object
    • dmr
    • medical-devices
    • regulated
  • Apr 25, 2026

    21 CFR Part 820 (FDA Quality System Regulation)

    • standard
    • fda
    • qms
    • medical-devices
    • regulated
  • Apr 25, 2026

    ISO 13485 (Medical Device QMS)

    • standard
    • iso
    • qms
    • medical-devices
    • regulated
  • Apr 25, 2026

    EU MDR (Regulation 2017/745)

    • standard
    • regulation
    • eu
    • medical-devices
    • regulated
  • Apr 25, 2026

    UDI

    • data-object
    • medical-devices
    • traceability
    • regulatory

Created with Quartz v4.5.2 © 2026

  • Methodology
  • Licensing
  • Roadmap
  • Site source (Quartz)