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Recent Posts

  • “You can’t just say the requirement came from the AI”
  • Who is EUMEDIQ, anyway? This time: Gabi
  • New MDCG Guidance: AI Act and MDR/IVDR – What MedTech manufacturers need to know
  • Radiation sterilisation, simplified: Lisa explains the key updates in ISO 11137-1
  • Ongoing Validation: Why Compliance Doesn’t Stop After Go-Live

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