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Most people underestimate what data management really means in medtech and IVD
In pharma, data management is typically focused on getting clean, consistent, and traceable clinical data—which means that data anomalies are usually handled du...
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Aurevia expert spotlight: 3 questions with our risk management expert
Meet Cristina Albu Barkman, Principal Consultant, and one of Aurevia’s most experienced specialists in medical device risk management. With more than 25 years i...
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Aurevia - your partner for oncology clinical trials
Oncology trials are complex—scientifically, operationally, and from a regulatory perspective. Our teams have both deep knowledge and hands-on experience, suppor...
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Bergius blir AxFlow – ett naturligt nästa steg
Två år efter förvärvet tar vi nu nästa steg: Bergius blir nu fullt ut AxFlow AB. Personalen följer med till AxFlow och bildar en egen avdelning som fokuserar på...
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Germany strengthens medical data governance – what it means for life science
On 11 March 2026, the German Federal Cabinet adopted the draft Medical Register Act (Medizinregistergesetz), introducing a uniform legal framework for medical r...
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Ny nivå av vakuum – helt utan olja.
Atlas Copco DHS 3000 VSD+ - Oljefri skruvvakuumpump för stora flöden!
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Meet Aurevia at the next Medicon Village Science for Breakfast
Join us for Science for Breakfast at Medicon Village on May 19th!
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Upcoming training: Cybersecurity standards for medical devices
This 1-day course on Cybersecurity standards for medical devices is designed to help professionals gain an understanding of the current standards within cyberse...
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Upcoming training: MD software process design based on IEC 62304
Together with Intertek Academy, we offer a 2-day course in Stockholm, Sweden, covering Medical device software process design based on IEC 62304. This course is...
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Medicon Village breakfast seminar: ISO 10993-1 in practice
Don't miss our breakfast seminar at Medicon Village on May 28th: ISO 10993-1 in practice - connecting biological evaluation to your technical documentation.
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Upcoming training: Introduction to ISO 15189:2022
Do you work with quality management in a medical laboratory? Don’t miss our ISO 15189:2022 online training course on May 12-13th — designed to help you understa...
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QAdvis is now Aurevia
Two years ago, QAdvis became part of something bigger. At first, the change was mostly visible on paper — a new owner and later a new name: Aurevia. But this wa...
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Unlocking the future of medtech
Navigating the European medtech regulatory jungle? Good news —real progress is ahead.
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Internal audits based on ISO 13485 for medtech organizations
Are you ready to turn your internal audits into real improvements? Internal auditing isn’t just about compliance—it’s a strategic tool for driving development a...
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ISO 20417 has been updated – what device manufacturers should consider
The new edition of ISO 20417 has been published, further clarifying expectations for information supplied with medical devices. Although not yet harmonized, the...
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Custom regulatory and clinical strategy workshops
A strong regulatory and clinical strategy early on can save months of rework later.
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New global standard for clinical evaluation is on the horizon: ISO/DIS 18969
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969. The core message is straightforward: clinical evaluations should be seen as a pr...
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Transport validation for medical devices
According to MDR 2017/745, “Devices shall be designed and manufactured in such a way as to ensure that their characteristics and performance during their intend...
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Supporting Investigator Initiated Clinical Studies—From Start to Finish
Many important clinical studies start with researchers – not pharmaceutical companies. In investigator initiated studies, pharmaceutical companies often support...
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Clinical trials: proposals, budgets, and the evolving CRO role
This podcast episode from Trustful Clinical Budgeting dives into what really makes proposals work in clinical trials and why clarity, early alignment, and reali...
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How MoniDose strengthened their regulatory confidence—fast
When MoniDose began their startup journey, regulations were their biggest challenge. Missing early design inputs tied to standards could have meant costly redesigns later.
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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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Quattroflow® lanserar ytterligare modell med ATEX-certifiering
I november 2025 lanserade Quattroflow® deras första fyra ATEX- certifierade modeller för kritiska bioprocesser. Nu utökar de ATEX-familjen med ytterligare en AT...
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Are you prepared for the updated ISO 10993 1:2025?
The latest edition of ISO 10993-1 reinforces the integration of biological evaluation with risk management, introduces updated approaches to exposure assessment...
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