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Understanding OOS and Deviations in the Medical Device Industry
29 January 2025
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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Key Considerations for EN IEC 60601-1 Testing
23 January 2025
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.
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What is Clinical Evaluation Equivalence and does that apply to your medical device?
16 January 2025
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.
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Position Paper of Team NB adopted: MDR Certification Process (including Pre-application, Application and Post Application phases)
14 January 2025
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
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EU: Commission publishes second draft of GPAI (General Purpose Artificial Intelligence) code of practice
6 January 2025
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.
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