Latest news from Kiwa

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 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.

To register medical devices with the MHRA, manufacturers must follow specific requirements and procedures.  In this article you will find the key steps and requirements.

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 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.

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.

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.

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.