Latest news from Kiwa

Placing medical devices in Great Britain and Northern Ireland: key differences and timelines

The rules for placing medical devices on the Great Britain (GB) and Northern Ireland (NI) markets differ primarily in terms of the timelines and regulatory frameworks

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Overview of AI-enabled SaMD and SiMD devices

Artificial Intelligence (AI)-based software medical devices are revolutionizing the healthcare sector in diagnosis, treatment, and patient management. AI-powered Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) applications cover a wide range of solutions, from medical decision support systems to patient monitoring tools.

UK Introduces Security Regime for Connectable Products

In a synchronized move following the European Union's footsteps, the United Kingdom has unveiled its own comprehensive cybersecurity requirements for connectable products. While the EU's requirements are slated to take effect on 1 August 2025, the UK's security framework is poised to be enacted earlier, starting from 29 April 2024.

Kiwa officially accredited for ISO 27001:2022

The Dutch Accreditation Council (RvA) has accredited Kiwa as of the 1st of February 2023 for assessment according to the ISO 27001:2022 standard for information security. This means that as of the 1st of March Kiwa may issue recognized certificates according to the latest version of ISO 27001.

Kiwa Cermet Italia achieves notification to the Medical Device Regulation (MDR)

Kiwa Cermet Italia has successfully achieved designation as a Notified Body for Conformity Assessment activities according to the Medical Devices Regulation 2017/745/EU.

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