Aurevia

26/09/2025

🌟 Medtechdagen 2025 — what an inspiring day!! 🌟
We’re still buzzing from all the great conversations, innovative ideas, and meaningful connections we made. It’s events like these that remind us why we’re passionate about driving change in healthcare through technology.

A heartfelt thank you to the organizers for putting together such an energizing event. Your work truly makes a difference! 🙏

💡 Let’s keep the momentum going — feel free to reach out if you’d like to continue the conversation. We’d love to discuss how our team of regulatory affairs, quality assurance, and clinical research experts can support you across the full product lifecycle–from early development to post-market phases worldwide.

Evaluation

25/09/2025

Introducing some of the speakers in the Clinical Evidence Generation program track at Labquality Days 2025! ❄️

❄️ Danielle Giroud from MD-CLINICALS SA
❄️ Laura Lang from JST Healthcare Solutions Oy
❄️ Angela Graf from Dr. Fandrich Rechtsanwälte
❄️ Antti Valanne from Sertio Oy
❄️ Kristofer Klerfalk from Life Science Invest
❄️ Kaisu Rantakokko-Jalava from Turku University Hospital

The lectures cover practical approaches and success factors in clinical investigation, health tech commercialization, and different types of studies, among other things.

Check out the full scientific program on the Labquality Days website 👉https://eu1.hubs.ly/H0nlyKL0

Labquality Days is one of Northern Europe's largest annual international congresses focusing on quality in laboratory medicine and health technology. 💡

24/09/2025

Incident reporting in MDR/IVDR – an opportunity more manufacturers should embrace

With 13 years of experience as a regulator, Marie Mathiasson, Senior Quality and Regulatory Consultant at Aurevia, offers insight into how trust is built (or lost) between manufacturers and authorities. As she puts it:

“When I worked on the authority side, I often saw two types of manufacturers: those who reported incidents openly and early – and those who tried to avoid it for as long as possible. The difference in trust was enormous.”

“Reporting brings so many advantages: you get early warning signals, build trust, and gain insights that can improve design, usability, and risk management. And most importantly – you demonstrate accountability.”

Marie emphasizes: “For me it’s obvious: incident reporting is not just a paragraph to comply with. It’s a tool for long-term quality and patient safety. Today, I help companies turn vigilance into value by building processes that strengthen patient safety and drive better business outcomes.”

Do you need support with vigilance? Let our experts help you navigate complex regulatory requirements and build processes that ensure trust and transparency.

23/09/2025

Get to know the laboratory experts speaking at Labquality Days 2026! ❄️

The first session in the Quality in Laboratory Medicine program track covers Analytical Quality Control, and we are delighted to welcome these laboratory experts to share their insights with us:

❄️ Tze Ping Loh, National University Hospital Singapore
❄️ Hikmet Can Çubukçu, Turkish Ministry of Health, EFML, IFCC
❄️ Panagiotis Tsiamyrtzis, Politecnico di Milano & Athens University of Economics and Business
❄️ Huub van Rossum, Netherlands Cancer Institute
❄️ Tomas Zima, Charles University, General University Hospital Prague, EFLM

Read their introductions and see the scientific program on our website: https://eu1.hubs.ly/H0nfyZ50

22/09/2025

Looking forward to meeting you at Medtech Day 🌟🤩

Medtech Magazine is turning 20, and we're joining the celebration at Medtechdagen (Medtech Day)! This exciting event brings together innovators, researchers, and decision-makers from across the medtech landscape🙌

Whether you need support with quality assurance, regulatory affairs or clinical research – or you just want to stop by for a great conversation – we hope to see you there!

Check out the program and learn more: https://eu1.hubs.ly/H0ncrQ30

19/09/2025

📄 Technical Documentation for Medical Devices – Online Course

Are you a QA or RA specialist working with development projects for medical devices? This course, developed in collaboration with Swedish Medtech, will help you master the essentials of technical documentation—from concept to market approval and beyond.

✅ Learn how to:
• Develop documentation throughout the device development process
• Navigate the requirements of technical documentation according to the MDR
• Avoid common pitfalls and streamline the notified body review process
• Update documentation after the product has been placed on the market

🎯 The goal? Get your product to market faster, so you can help patients and drive business success.

👩‍🏫 Led by Caroline Ehrenborg, Senior Quality & Regulatory Consultant
📍 Online session: 15 October, 09.00–15.00
💰 Price: 5800 SEK (4100 SEK for Swedish Medtech members) (excl. VAT)
🗣️ Verbal presentation in Swedish, course material in English
📜 Certificate upon completion
📩 Learn more and register: https://eu1.hubs.ly/H0nbJKh0

19/09/2025

Labquality Days turns 50 next year! ❄️

Have you visited the congress during the last 50 years? What has been the most memorable lecture, meeting, or evening event for you?

Please share your favourite memories with us! You will take part in a raffle, and we will also share the best memories on social media and at the event! Take part on our website 👉 https://eu1.hubs.ly/H0n89mq0

18/09/2025

📄 Strategic Insights for a Successful 510(k) Submission
In Part 3 of our FDA “radical transparency” article series, we explore how medical device manufacturers can strengthen their 510(k) submissions through strategic planning, consistency, and proactive engagement.

💬 As Ferenc Dahnér, Senior Quality & Regulatory Consultant at Aurevia, puts it: “Successfully navigating the FDA’s 510(k) pathway requires more than compiling test data. It necessitates strategic foresight, sound regulatory judgment, and a thorough understanding of the Agency’s evolving expectations.”

From selecting an appropriate predicate device to managing post-submission timelines, this article offers practical guidance to help sponsors avoid common pitfalls and position their devices for success.

👉 Read the full article: https://eu1.hubs.ly/H0n9vgt0

17/09/2025

🧡 Today is World Patient Safety Day!
World Patient Safety Day encourages patients, policy makers, families, and caregivers to work collaboratively to improve patient safety.

We’re thankful for this global reminder that patient safety is a shared responsibility. By working collaboratively, healthcare policies and interventions can be designed to truly reflect patients’ needs.

When patients stay empowered, informed, and involved, patient outcomes and quality of life can be improved. 🙏 Let’s continue to build a culture of safety, transparency, and collaboration across all levels of care. Because every patient deserves safe, high-quality healthcare.

Together, we can contribute to better health for all!

15/09/2025

🎯Is your post-market surveillance (PMS) a strategic asset—or just paperwork?

Too many medtech companies treat PMS as a regulatory checkbox. But what if it could be your competitive edge?

Anna-Karin Alm, Head of QARA at Aurevia, shares why PMS is more than compliance—it's a powerful tool for patient safety, product improvement, and building trust in your brand.

👉 Read the full article: https://eu1.hubs.ly/H0n0HBB0

Uppföljningen av produkter som släppts borde inte ses som en börda, utan som en investering i kvalitet och säkerhet. Det skriver Anna-Karin Alm i en krönika.

10/09/2025

🔍 FDA’s “Radical Transparency” – Are You Ready?
In Part 2 of our article series, we explore how medical device companies can proactively adapt to the FDA’s evolving transparency initiative. With the potential public disclosure of rejection letters, regulatory strategy is not just about compliance—it’s about credibility.

As Ferenc Dahnér explains, “Companies should operate under the assumption that rejection letters may eventually be disclosed and develop their communication strategies with this in mind.”

He also emphasizes: “Importantly, the same strategies that help mitigate risks under increased transparency also serve to strengthen the likelihood of a successful submission.”

👉 Read the full article to learn practical strategies to mitigate risks, ensure compliance, and safeguard your long-term business continuity: https://eu1.hubs.ly/H0mXLPZ0

09/09/2025

ISO 27001🔐 Proven Expertise in Information Security
Our commitment to excellence in information security is backed by our in-depth expertise in ISO 27001, the international standard for Information Security Management Systems (ISMS).

At Aurevia, we don’t just implement ISO 27001— we tailor it to the unique needs of companies operating in the health sector, such as medical device manufacturers.

Our deep understanding of medical devices, quality management systems (QMS), and cybersecurity requirements allows us to identify synergies between these domains and build more meaningful, integrated ISMS frameworks that support your business and compliance goals.

✅ Why it matters: In today’s digital landscape, protecting sensitive data is essential. ISO 27001 provides a systematic approach to managing information security — and when combined with domain-specific expertise — it becomes a strategic asset that can enhance regulatory compliance and support innovation.

💡 How we can support you:
• Assess your current security practices and identify gaps (internal auditing)
• Design and implement ISO 27001-compliant processes tailored to health industry needs
• Align ISMS with QMS and cybersecurity frameworks
• Prepare for audits and certification
• Provide training and ongoing support to foster security awareness and sustainability

Whether you're looking to setup your information security framework or refine your existing one, our experts can help you create a system that’s not just compliant, but also strategically aligned with your operations.

📩 Let’s talk about how we can support your business goals.