Latest news from Kiwa

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.

Key Considerations for EN IEC 60601-1 Testing

EN IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, is a harmonized standard that outlines the essential safety and performance criteria for active medical devices. Incorporating this standard during the design phase of electrical medical devices is crucial.

What is Clinical Evaluation Equivalence and does that apply to your medical device?

Are you considering substantiating the clinical data of your device based on an equivalence device? Do you have full access to clinical data for technical, biological and clinically similar devices and you wish to leverage that to prove compliance for another device?  This article could help you get a feeling of whether this could be an option.

Heat Pump – Performance test laboratory now operational

We're excited to announce that Kiwa’s new Heat Pump Performance Test Laboratory in Padua is now operational. Equipped for EN 14511, EN 14825, and EN 16147 tests, it ensures high accuracy, automated processes, and ISO/IEC 17025 accreditation. With cutting-edge facilities, Kiwa is able to support reliable, sustainable heating and cooling solutions.

Position Paper of Team NB adopted: MDR Certification Process (including Pre-application, Application and Post Application phases)

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

Wergeland Bedriftsutvikling becomes part of Kiwa

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.

Strengthening Regional Expertise: Kiwa Group Expands in the US with Two New Additions

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 Returns to ISH 2025 – Shaping the Future of Water and Energy

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 and KNRB extend and strengthen partnership

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.

Intelligent Drone & Robot Inspections: Partnering with SkyeBase

Vinçotte, a Kiwa company, is teaming up with SkyeBase, a Belgian leader in drone and robotic inspections, to redefine the future of intelligent and digital inspection services.

Kiwa strengthens global presence with key addition of companies in US, UK and China

Kiwa is expanding its global presence, following an agreement with Element Materials Technology (“Element”), through the addition of NQA (USA, UK and India), the management systems certification division of BM Trada (UK), Unitek (USA), the technical services division of Trialon (USA), and the remaining 50% stake in SNQA, a joint venture partner (China). These businesses bring Kiwa additional expertise across a wide variety of markets and throughout the global Testing, Inspection and Certification (TIC) sector.

Vinçotte presents innovations at Sprint Robotics World Conference in Antwerp

Vinçotte, a member of the Kiwa Group, will be attending the SPRINT Robotics World Conference for Inspection & Maintenance Robotics 2024 in Antwerp on 29-30 October. Visit us at stand L5 to explore our latest robotics innovations for industrial inspections.

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