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Articles by Eu Mdr
If Your AI Can't Explain Itself, Can FDA Authorize It?
Consider a hypothetical scenario that reflects a pattern increasingly reported by manufacturers: a 510(k) submission for an AI-powered diagnostic tool with 99% sensitivity. Strong numbers. Solid validation. And yet — a deficiency letter comes back from FDA. Not because the model underperforms. Because reviewers cannot determine what it is actually doing or why. This is the reality manufacturers are running into as AI/ML-based Software as a Medical Device (SaMD) enters the 510(k) and De Novo pathways.
From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market
Pediatric wearables are often treated as a niche extension of adult digital health, but that framing misses the real challenge. The hardest part is not miniaturizing the technology for smaller bodies. It is designing for a patient population that is constantly changing (physically, cognitively, behaviorally, and clinically) from infancy through adolescence.
PSD Bank Rhein-Ruhr eG
C2A Security Acquires Vigilant Ops, Creating a Global Market-Leading AI-Powered Product Security Powerhouse, adding Tens of MedTech, Telecom, and Defense Customers EQS-News: C2A Security / Key word(s): Mergers & Acquisitions C2A Security Acquires Vigilant Ops, Creating a Global Market-Leading AI-Powered Product Security Powerhouse, adding Tens of MedTech, Telecom, and Defense Customers 17.10.2025 / 09:05 CET/CEST The issuer is solely responsible for the content of this announcement.
Three-quarters of medical device companies are ready to meet EU MDR and IVDR regulations
Liane McIvor 10th May 2021 Three-quarters of medical device companies are ready to meet EU MDR and IVDR regulations2021-05-10T13:53:05+01:00 Newsroom, Reports & Research, Sector News A research report from RWS, a provider of technology-enabled language, content management and intellectual property services, has painted an optimistic picture about the readiness of medical device manufacturers to meet the European Union’s (EU) Medical Device regulation (MDR) and In Vitro Diagnostic Regulation...
Comment: Why Class III EU MDR compliance efforts provide a wake-up call
The spectre of EU MDR is looming large over the medical device industry in what is bound to be a continuous flow of new regulations coming down the pipeline for different types of medical devices in the coming years. Bob Tilling, VP Global Sales at Kallik, shares his experiences of working with Class III manufacturers to prepare for May 2021 – and highlights the need for Class II businesses to learn from mistakes made and not delay preparations to meet their own UDI labelling deadline in 2023.
EU MDR Strategy: How to Effectively Deploy Consultant Partnerships
The delay of the EU MDR deadline to May 2021 provides medical device manufacturers with a window of opportunity to address their compliance challenges. Businesses must plan carefully to understand where they are at in their compliance roadmap and whether they will be able to meet the requirements within the timeframe, and to an adequate level. Strategic regulatory partners can help to make the planning and implementation process more efficient by offering expert support as and when it is needed.
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