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Artificial intelligence in medical device - It's raining standards
While lot's of people wait for the 2nd version of IEC 62034, lots of other standards are being published or in the works. A few years back, IEC 62304 was alone on the scene. Then came IEC 82304-1. Now,...
View ArticleIMDRF N93 Technical Framework for Artificial Intelligence Life Cycle Management
The International Medical Device Regulators Forum (IMDRF) published a draft version of their guide on artificial intelligence lifecycle management for medical devices.IntroductionThis document has the...
View ArticleIEC PAS 63621 2026 published
IEC PAS 63621 2026 - Artificial intelligence enabled medical devices - Data management, has been published in March 2026. A PAS is a Publicly Available Specification, a kind of early version of a...
View ArticleClaude Code: your new QARA team
People say AI is going to replace their job. This is not true. People using AI are going to replace people who don't. My experience using Claude code from Anthropic perfectly demonstrates...
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New Templates: Data Management Plan and Data Management Report
After talking about AI in a series of articles, and especially about the data management process, we introduce two new templates: the Data Management Plan and Data Management Report.Current templates...
View ArticleNew version of FDA guidance on Clinical Decision Support Software
A new version of the FDA Guidance on Clinical Decision Support Software (CDSS) was published in January 2026. Here is a review of the new cases presented in the document and a short comparison with the...
View ArticleTUV.AI Lab whitepaper on ISO 14971 - mind the gap ... or not
The TUV.AI Lab published in November 2025 a white paper on gaps between ISO 14971 and risk management requirements present in article 9 of the AI Act.Comparison of AI Act article 9 and ISO 14971The...
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Proposal for MDR/IVDR changes and Rule 11 - software classification
Lots of fuzz and buzz on the proposal for MDR/IVDR changes published on the 16th December 2025. First, keep in mind this is a proposal. Second, keep calm and wait for the version amended and voted by...
View ArticleArtificial Intelligence in Medical Devices - Part 5 Cybersecurity
After safety risks in the previous post, we continue this series of posts on AI with Cybersecurity risks.Cybersecurity is vast subject. It can be separated in security at IT level (the organization)...
View ArticleFinal FDA CSA guidance released
The final version of the FDA guidance on Computer Software Assurance was published in September 2025, three years after its draft version.Here are the changes, compared to the draft version, already...
View ArticleArtificial Intelligence in Medical Devices - Part 4 Risk Management
We continue this series of articles on Artificial Intelligence with the Risk Management Process. Simply put, risk management for MDAI isn't dramatically different from risk management for classical...
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Artificial Intelligence in Medical Devices - Part 3 Data Management
We continue this series of articles on Artificial Intelligence with the Data Management Process. This process is required by article 10 of the AI Act, but also from a MDR viewpoint to document the...
View ArticleTÜV AI.LAB White Papers - whack a mole game
The TÜV AI.Lab published two white papers on the interaction between the AI Act and the MDR:Better Safe Than Sorry? ISO 13485 and the EU AI Act and:AI Act and MDR - A match made in heaven or double the...
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Artificial Intelligence in Medical Devices - Part 2 Design
After introducing this series in the previous post, we continue with MDAI design.AI design is different from SW design. That's why IEC 62304 in its current version doesn't help for AI design. It...
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Artificial Intelligence in Medical Devices - Part 1 Introduction
We start here a series of articles about artificial intelligence (AI) in medical devices (MD). This series will consider mostly machine learning (ML), the most widespread type of AI. The one, which...
View ArticleAIB 2025-1 - MDCG 2025-6 - Welcome to the AI Act, MD manufacturer
The Artificial Intelligence Bureau (AIB), in charge of some regulatory aspects of the AI Act, and the MDCG published in June 2025 a common guidance. This guidance is a FAQ, it will be updated when new...
View Article2025 update of FDA Premarket Cybersecurity guidance
A new version of the FDA guidance named Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions was published in June 2025. The body text had minor updates:...
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Rogue 11: a MDR story
MDCG 2019-11 rev.1 was published in June 2025. Almost 6 years after the first version. Despite the passage of time, and the advent of modern AI, nothing has really changed. The rigorous approach is...
View ArticleTeam-NB position paper on EU AI Act
The Team-NB published the V2 of a position paper on the EU AI Act in April 2025. It's interesting to see that this paper was published just before the white paper from BSI.This document is the V2 of a...
View ArticleBSI White paper: The EU AI Act meets the MDR
BSI Notified Body published in May 2025 a new White Paper on the AI Act and its interactions with MDR / IVDR.This white paper is a summary of AI Act content and its interactions with MDR / IVDR. It...
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