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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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Extension of MIL-STD-461 Testing Capabilities – Now Including CS-115 and CS-116

We’re proud to announce that SIQ Ljubljana has extended its testing capabilities under the MIL-STD-461 standard — a critical benchmark for electromagnetic compatibility (EMC) in defence and aerospace applications. Our laboratory is now fully e...

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Update on EN IEC 62368-1:2024 + A11:2024 and OJEU Harmonization Status

Earlier this year, CENELEC TC108X addressed the initial comments raised during the HAS consultant assessment and prepared a draft prA12 amendment intended to resolve the identified non-compliances. At that time, there was cautious optimism that th...

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SIQ Extends Accreditation to the Full EN 18031 Cybersecurity Standard Series

We are pleased to announce that, in early November, SIQ successfully extended its accreditation scope to include the complete set of cybersecurity standards EN 18031-1, EN 18031-2, and EN 18031-3. The EN 18031 series is the newly harmonized st...

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Criteria for Rated Output Power and Current of Power Supply Units (PSUs)

In 2024, the OSM/EE concluded that a power supply unit that does not achieve its declared rated output power or rated output current cannot be considered compliant with the applicable standard. This interpretation was issued without specifying any...

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