Latest news from Kiwa

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 as its 30th testing lab, strengthening quality assurance and reliability in heat pump certification.

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.

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.

The Position Paper “MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document” was adopted by the Team NB members and published on December 18th 2024.  This Position Paper is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before and is aligned to the requirements of MDR

Kiwa Norway expands by welcoming Wergeland Bedriftsutvikling AS (WBU) into the group. With expertise in management systems, risk mapping, and digital solutions, WBU strengthens Kiwa’s service portfolio. Together, they’ll offer enhanced services in sustainability, cyber security, and energy management, driving value and innovation for customers across various industries.

On December 19, 2024, the European Commission published the second draft of the 'General-Purpose AI Code of Practice.' Independent experts present the second draft of the General-Purpose AI Code of Practice, based on the feedback received on the first draft, published on 14 November 2024. 

Kiwa Group is pleased to announce its recent expansion in the US with the addition of two new companies, Browne Engineering Partners, Inc. and GeoScan Subsurface Surveys, Inc. 

Kiwa is excited to announce its participation in ISH 2025, the world’s leading trade fair for HVAC + Water, taking place from 17-21 March in Frankfurt, Germany. As the global event for water, heating, ventilation, and air conditioning, ISH sets the stage for innovation and sustainability in a dynamic industry landscape.

Kiwa renews its partnership with the Royal Dutch Rowing Federation (KNRB) for two more years, continuing support since 1992. Together, they champion quality, safety, and sustainability in rowing, inspiring future athletes and fostering community growth. Kiwa’s logo will feature on TeamNL Rowing’s boats as they prepare for the 2026 World Championships.