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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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Medtech Compliance Forum: Explore This Year's Programme Tracks
The Medtech Compliance Forum by Aurevia & RAPS is a dedicated platform within Labquality Days, bringing together regulatory, quality, clinical and technical per...
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Need support with EUDAMED?
EUDAMED registration is now an important part of regulatory compliance for medical device and IVD companies operating on the EU market.
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Improved flexibility for CTIS submissions
A new “Article 11 workaround” is addressing a long-standing limitation in CTIS when working with Part I-only submissions in multi-country clinical trials.
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Strategic Communication: Develop your QA role
Strengthen your QA role with practical communication skills to engage, influence and create understanding.
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Master Medical Device Sterilization
The Essential 4-Day Training for Auditors, Assessors, and Quality Professionals
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European Authorised Representative (EAR): Your partner for EU market access and compliance
For non-EU/EEA companies expanding into the EU market as a medical device or IVD manufacturer, appointing a European Authorised Representative (EAR) is a legal ...
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Why are Aurevia and RAPS collaborating on the Medtech Compliance Forum?
We asked Mika Siitonen, Operations Manager, Digital Health at Aurevia, and the lead for the Medtech Compliance Forum, to explain the thinking behind the collabo...
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Osynliga läckage, tydliga vinster.
Från bubbeltest till avancerad säkerhet: bättre läckagedetektering för livsmedelsförpackningar av hög kvalitet. Föreställ dig att du förbereder en flaska moders...
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Recent clarification in Sweden’s clinical trial legislation
From 1 July 2026, a clarification in the Swedish Medicines Act has further defined the role of legal representatives in clinical trials—specifically their respo...
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Strengthen your team with Clinical and Regulatory Experts
Not every challenge calls for a permanent hire.
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Clinical and regulatory expertise that delivers results
Organizations in the life sciences sector are under constant pressure to meet regulatory requirements, maintain clinical study timelines, and ensure inspection ...
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Medtech Compliance Forum by Aurevia & RAPS
We are excited to announce that registration is now open for the Medtech Compliance Forum by Aurevia & RAPS, taking place as part of Labquality Days 2027 in Helsinki, Finland.
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Experienced clinical and regulatory support for a busy autumn
The post-summer backlog is real.
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Expanding into the EU market?
Expanding into the EU market as a medical device or IVD manufacturer? For non-EU/EEA companies, appointing a European Authorised Representative (EAR) is not jus...
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Att välja rätt material för membranpumpen
Att välja rätt material för membranpumpar är avgörande för att säkerställa tillförlitlig, säker och kontamineringsfri drift i industriella tillämpningar. Materi...
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Flexible clinical research support for your urgent project needs
When resources are stretched or timelines are tight, waiting is not an option.
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Streamline medical device development with an integrated platform
Developing medical devices (MD) today means navigating complexity—regulatory requirements, documentation, risk management, and fast-moving innovation. What if y...
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Imaging Core Lab and Clinical Adjudication in Clinical Studies
At Aurevia, we offer centralized adjudication and core lab services where experienced clinical experts, in close collaboration with our project managers, ensure...
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Strömberg Distribution – logistik, beredskapslager inomLife Science
Strömbergs centrala del av verksamheten är inom Life Science och möjligheten till beredskapslager, där kritiska produkter lagras för att garantera leveransförmå...
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