Latest news from Kiwa

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.

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Medical equipment close-up in a healthcare facility, displaying vital signs on a monitor, with healthcare professionals in scrubs and masks in the background

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

Kiwa at PRSE 2025

The plastics industry is transforming, with recycling and sustainability at the heart of its future. As regulations become stricter and consumers demand more environmentally friendly solutions, ensuring quality, compliance, and innovation in recycled plastics is more important than ever.

Fit4DW materials database speeds up certification

Kiwa, DVGW CERT, and figawa are launching the Fit4DW materials database at ISH 2025. This platform simplifies the certification of drinking water materials, ensuring compliance with EU regulations. By centralizing verified data, it reduces certification time by up to nine months, saving costs while ensuring safe, high-quality water.

Medical device registration in Great Britain and Northern Ireland

Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates in Great Britain (GB) and Northern Ireland (NI).

Kiwa and Vinçotte: Key Partners in the Horizon Europe SYRIUS Project

Kiwa and Vinçotte are proud to be key partners in the Horizon Europe SYRIUS project, which aims to revolutionize steelmaking by integrating hydrogen into the production process. This groundbreaking initiative will significantly reduce CO2 emissions and improve energy efficiency. With Kiwa's expertise in safety and certification, and Vinçotte’s focus on compliance, the project sets new standards for sustainable steel production and industrial innovation.

Group photo at the SYRIUS Kick Off Meeting, featuring diverse participants standing in front of a projector screen, with flags and bookshelves in the background

Kiwa Retains 5-Star BRCGS Rating for Another Year

Kiwa has retained its 5-star BRCGS rating across multiple countries, reaffirming its commitment to food safety and quality assurance. This recognition highlights Kiwa’s excellence in compliance, auditing, and supply chain integrity. Discover how Kiwa continues to support global food safety with trusted certification and verification services.

Kiwa food inspector inspecting apples on a conveyor belt during an audit with a tablet in a food processing plant

Importance of and effective Post Market Surveillance (PMS) – The view of the Dutch Competent Authority (IGJ).

The Health and Youth Care Inspectorate (IGJ) has identified significant deficiencies in post-market surveillance (PMS) among medical device manufacturers in the Netherlands.​ IGJ urges manufacturers to prioritize PMS, enhance their knowledge, and ensure compliance to improve device safety and performance.​  

Navigating the Regulatory Landscape for Drug-Device Combinations: Key Highlights and Compliance Essentials from EMA (European Medicines Agency)

A new revision of Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) has been published.  

Enhancing usability in medical devices: A key to MDR compliance and patient safety

In the ever-evolving field of medical technology, usability engineering has become a critical factor in ensuring patient safety and regulatory compliance. The MDR (Medical Device Regulation) places a strong emphasis on usability engineering. Compliance with IEC 62366-1 and IEC TR 62366-2 is not just a regulatory requirement but also a best practice for designing medical devices that are safe, effective, and user-friendly.

Kiwa Creiven Joins Heat Pump KEYMARK

Kiwa Creiven joins Heat Pump KEYMARK as its 30th testing lab, strengthening quality assurance and reliability in heat pump certification.

PRRC vs UKRP: Navigating medical device regulatory responsibilities

Two key roles in the medical devices sector are the Responsible Person for Regulatory Compliance (PRRC), which is a requirement under the EU MDR (2017/745) and IVDR (2017/746), and the UK Responsible Person (UKRP), which is mandated under the UK MDR 2002 (SI 2002/618, as amended). While their names may sound similar, their responsibilities and legal implications are quite different.

Understanding OOS and Deviations in the Medical Device Industry

In the medical device industry, maintaining quality and compliance is paramount to ensure patient safety and product efficacy. Two critical concepts that often arise in this context are Out-of-Specification (OOS) events and Deviations. While both indicate potential quality or compliance concerns, they differ significantly in their focus, triggers, and resolutions.

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