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Organization Certification

From Development to Patient: Ensuring the Safety of Medical Devices

Ensuring and verifying the safety of medical devices is essential for their safe use and for protecting patients. The final product must operate safely and reliably under all intended conditions of use, whether it is a simple m...

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SIQ Summit 2026 Successfully Concludes, Bringing Together More Than 400 Participants from 20 Countries

On 27 and 28 May 2026, SIQ successfully hosted the inaugural SIQ Summit – International Compliance Conference at the Brdo Congress Centre, Slovenia. The event brought together more than 400 participants from 20 countries, confirmi...

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Software Requirements in Medical Devices

26. February 2026 Organization Certification

The ISO/IEC 81001-5-1 standard defines requirements for the secure design, development, and maintenance of software used in medical devices, with a strong emphasis on testing to manage cybersecurity risks.

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SIQ Ljubljana celebrates collaborative influence with IQNET

10. November 2025 Organization Certification

Ljubljana, 10 November 2025 – SIQ Ljubljana as IQNET Member is one in celebrating the network’s 35th year. 

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AI Act and Medical Devices

27. August 2025 Organization Certification

Medical devices must meet strict requirements regarding safety and clinical effectiveness. A systematic assessment of risks and benefits is required throughout the entire life cycle of a device. Clinical investigations and post...

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