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UK plans permanent recognition of CE-marked medical devices
Good news for medical device manufacturers targeting the UK market.
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3PL- där kvalitet aldrig kompromissas
Strömberg Distribution Norden är specialiserade på logistiklösningar för Medtech, Life Science och andra verksamheter där kvalitet aldrig får kompromissas. Med ...
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Upcoming Course: Internal Audits Based on ISO 13485 for Medtech Organizations
Are you ready to turn your internal audits into real improvements?
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From legacy devices to software IVDs: Medtech Compliance Forum puts the spotlight on IVDR compliance
The IVD landscape continues to evolve. Are you ready for what's next?
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What if some of the most influential systems in healthcare are the least regulated?
While MDR has placed high demands on medical device manufacturers, a new reality is emerging in healthcare. AI‑based triage tools, prioritization systems, and d...
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From regulatory requirements to clinical reality: putting clinical & performance evidence into focus
Clinical evidence remains one of the most challenging areas of medical device compliance. What do notified bodies expect? How can real-world and digital evidenc...
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AI in Medical Devices: Understanding the Review Process and Common Gaps
Join GBA Key2Compliance and BSI for a free webinar on 19 November 2026, 13:00–14:00 CET, exploring the regulatory review process for AI-enabled medical devices....
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Upcoming Course: Quality Management System according to EN ISO 13485:2016 - in practice
Do you work with medical devices? Understanding and implementing a robust Quality Management System (QMS) is key to regulatory success—and often a prerequisite for CE-marking.
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QAdvis & Scandinavian CRO are now Aurevia
Two years ago, we became part of something bigger. At first, the change was mostly visible on paper — a new owner and later a new name: Aurevia.
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Pumphuvudkonfiguration: Optimera flöde och vakuumprestanda
Konfigurationen av en membranpumps pumphuvuden spelar en avgörande roll för att bestämma dess flöde, vakuumkapacitet och totala prestanda. Medan membranmekanism...
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From innovation to compliance: Medtech Compliance Forum by Aurevia & RAPS explores health technology
How do you ensure innovation keeps pace with regulation? AI, software as a medical device, lifecycle management, post-market monitoring, clinical evidence, and ...
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Your UKRP Partner for Medical Device Market Access in the UK
Entering the UK market requires more than just registration—it requires the right regulatory partner.
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Medical Device Software Process Design: Why IEC 62304 Matters
How confident are you that your medical device software processes could withstand a regulatory review?
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Upcoming Course: Medical Device Software Process Design Based on IEC 62304
Do you work with medical device software process design? Together with Intertek Academy, we offer a 2-day course covering medical device software process design...
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Free webinar: Quality Risk Management & Root Cause Investigations
Join our free webinar on 22 October, 15:00–15:30, for an introduction to quality risk management and root cause investigations in the pharmaceutical and medical...
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Strömberg distribution Norden- en strategisk beredskapsresurs
Sveriges beredskap avgörs inte bara av vad som finns i beredskapslagren, utan också av hur snabbt kritiska produkter kan lagras, hanteras och distribueras när e...
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Change begins with the world's best question
What makes a change effort succeed while others struggle to gain traction?
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The Three Pillars of Clinical Evidence Under the IVDR — What Manufacturers Need to Know
The IVDR raises the bar. Many in vitro diagnostic (IVD) medical device manufacturers still underestimate how significantly the IVDR (EU) 2017/746 has raised the...
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Webinar – Is your AI software a medical device?
Join our free webinar on 29 October 2026, 13:00–13:45 CET, with Oscar He Lindholm, Client & Business Development Partner at GBA Key2Compliance. Oscar will expla...
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The IVDR Transition Is Not Over: Key Deadlines and Common Pitfalls
While the transitional periods have been extended through Regulation (EU) 2024/1860, the extension is not automatic. IVD manufacturers must meet specific interi...
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100 000 timmar av beprövad tillförlitlighet: KNF:s membranpumpar sätter en ny standard
Tillförlitlighet är inbyggd i varje KNF-pump. I ett långtidstest uppnådde KNF:s membranpump NMP 850.1.2 mer än 100 000 driftstimmar under definierade testförhål...
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Upcoming Course: Clinical Evaluation
This half day course will help you gain an understanding about the requirements on clinical data and clinical evaluation.
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Nautilus Fluidics Simulation Application finns nu tillgänglig
KNF:s webbaserade Nautilus-applikation finns nu tillgänglig för kundtest på KNF.com.
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Upcoming Training: IEC 62366 Medical Device Usability
This 1-day course on IEC 62366 Medical Device Usability, in collaboration with Intertek Academy, is designed to help professionals gain an understanding of the ...
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