Software in Medical Devices, by MD101 Consulting

Software in Medical Devices, by MD101 Consulting

Software in Medical Devices, by MD101 Consulting
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« December 2025 - Archives

January 2026

Friday, 23 January 2026

New version of FDA guidance on Clinical Decision Support Software

By Mitch - no comments - no trackbacks

Friday, 9 January 2026

TUV.AI Lab whitepaper on ISO 14971 - mind the gap ... or not

By Mitch - no comments - no trackbacks

Go to MD101 Consulting website

Pages

  • How to qualify, classify and CE mark software
  • Medical Device Software Trainings
  • Templates Repository for Software Development Process
  • The essential list of guidances for software medical devices

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  • Templates Templates Repository for Software Development Process
  • Guidances The essential list of guidances for software medical devices
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  • Regulations (97)
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Links

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  • The MedTech Alliance
  • .EMT Alliance (in French)
  • Qualitiso.com (in French)
  • Bob on medical device software
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