Aurevia

28/07/2025

🚀 Looking to enter the EU medical device market?

Navigating European regulations can be complex—but you don’t have to do it alone.

We specialize in supporting non-EU manufacturers with expert guidance on regulatory compliance, EAR representation, and quality system management. As proud members of the European Association of Authorised Representatives (EAAR), we help you meet EU requirements efficiently and confidently.

From risk management to post-market surveillance, we’re your trusted partner every step of the way.

Ready to expand into Europe? Contact us, we would love to hear about how we can help you enter and succeed in the EU market.

21/07/2025

👉Usability isn’t optional - it’s essential.

In medical device development, usability directly impacts effectiveness, safety, and overall user experience.

We help manufacturers integrate usability engineering throughout the product lifecycle, ensuring devices are intuitive, safe, and compliant with international standards like IEC 62366-1. From tailored training to hands-on support, we guide you in building a robust usability engineering file that meets regulatory expectations.

Contact us to find out how we can help you make your medical devices safer and more effective - by design.

17/07/2025

New EQA pilot studies for the autumn have been launched!

We actively follow the development of laboratory medicine and launch new pilot studies regularly to serve clinical laboratories and point-of-care sites. The newest pilot studies are:

💡 BPhosphatidyl ethanol in blood (PEth)
💡 West Nile Virus, antibodies

Read more and register for the pilots before September: https://eu1.hubs.ly/H0lMNNh0

16/07/2025

Are you ready for Labquality Days 2026? ❄️

Secure your spot now with Super Saver tickets that are available only until 31 August!

Join top experts at the International Congress on Quality in Laboratory Medicine and Health Technology. The full scientific programme launches on 1 September, but early registration ensures your place at the best rate. ✨

Register now: https://eu1.hubs.ly/H0lzhCX0

14/07/2025

⚠️ Risk management isn’t just a regulatory checkbox—it’s a cornerstone of safe, effective medical devices.

We help you elevate your risk management practices to meet the latest expectations of ISO 14971 and integrate them seamlessly into your quality system.

How can we help?
• Develop clear descriptions of the risk management process in accordance with applicable standards and regulations.
• Implement and maintain the risk management process across your organization.
• Prepare comprehensive risk management plans and reports tailored to your product lifecycle.
• Conduct a thorough risk analysis covering design, manufacturing, quality, usability, software, and cybersecurity.
• Evaluate and document benefit-risk assessments.
• Respond confidently to risk-related inquiries from notified bodies and authorities.
• Deliver customized and open training programs for medical device risk management.

Contact us to find out how we can support you - so that you can make risk management a strategic advantage for your organization.

07/07/2025

🔐 Cybersecurity in medical device software: a team effort

In today’s connected healthcare landscape, cybersecurity is essential. Developing compliant, secure medical device software requires close collaboration between software engineers, QA, regulatory experts, and clinicians throughout the lifecycle.

We help organizations streamline their software development processes while meeting the rigorous demands of CE-marking and FDA approval. Our team of experts can support you in embedding cybersecurity into every phase of development.

✅ Requirements specification
✅ Risk management
✅ Design & development
✅ Verification and validation
✅ Deployment and integration
✅ Maintenance and updates
✅ Documentation and traceability

Let’s build safer, smarter healthcare technology—together.

30/06/2025

Why a robust Design & Development process matters in medtech 💪

In the fast-evolving world of medical devices, a robust Design and Development (D&D) process isn't just best practice—it’s a business-critical necessity. From risk mitigation to faster time-to-market, the right D&D framework can make all the difference.

Check out this insightful article on how medical device companies can strengthen their D&D processes to drive innovation and ensure compliance:

👉 Read the full article: https://eu1.hubs.ly/H0lmVbG0

27/06/2025

🌟Summer greetings 🌟
As summer arrives, we’d like to take a moment to send our warmest greetings and sincere thanks. 🙏

This season marks an exciting new chapter for us, as we continue moving forward as Aurevia with our new organizational structure. While change brings growth, it also highlights the value of strong relationships—and we’re grateful for the continued collaboration and trust of our clients and partners, both old and new.

We also want to express our appreciation to our dedicated colleagues during this time of transformation. Your commitment and teamwork are the key to our success and continued development.

We hope you take the opportunity this summer to recharge and spend quality time with family and friends. We look forward to reconnecting after the summer and continuing our journey together. Wishing you a restful and inspiring summer! 🌞

If you have questions or need support, contact us at https://eu1.hubs.ly/H0llGnz0. Our offices are open during the entire summer.

17/06/2025

Tough times require sharp strategies – and the right expertise

The industry's financing climate has slowed down considerably. Investments in the development of pharmaceuticals and medtech are more cautious, and Ulrika Hammarström, Head of CRO at Aurevia, emphasizes that the requirements for a clear market and regulatory strategy have never been higher. For pharmaceutical, biotech and medical device companies that want to reach the market and remain there, she underscores that expert support is no longer an option, but a must.

As Anna-Karin Alm, Head of Quality Assurance and Regulatory Affairs (QARA) at Aurevia puts it: "Medical device companies operate in an extremely challenging environment right now, both in terms of requirements for product development but also in terms of business strategy. Conditions are constantly changing – today faster than ever. Given the global uncertainty, especially related to trade policy, it is crucial to understand how to create – and maintain – success in your business. We guide companies all the way, from early development to market entry and beyond. It is not enough to just get a product approved; It's about achieving success in the market by anticipating changes that may affect the product's lifecycle and staying up to date on regulatory requirements," she says.

Read the full article in Swedish:

Branschens finansieringsklimat har hårdnat rejält. Investeringarna i utveckling av läkemedel och medicinteknik är mer avvaktande, och Ulrika Hammarström på Aurevia betonar att kraven på tydlig strategi, marknadsfokus och regulatorisk träffsäkerhet därför aldrig varit högre. För företag...

09/06/2025

Registration is open for Labquality Days 2026! ❄️

Join us in celebrating the 50th edition of one of Northern Europe’s leading congresses on quality in laboratory medicine and health technology.

Super Saver prices are available until 31 Aug 2025, so secure your spot early! The complete scientific program will be launched on 1 September.

Topics include:
🔹 Analytical quality control
🔹 Direct-to-consumer testing
🔹 AI and regulatory insights
🔹 IVD and clinical evidence

📍 Helsinki, Finland
📅 5–6 Feb 2026

Register now: https://eu1.hubs.ly/H0kKDrb0

06/06/2025

We’re hiring! 🌟Join our CRO Services team in Sweden as a Clinical Research Associate (CRA). This is a permanent, full-time role based in Gothenburg or the Stockholm/Uppsala area.

You’ll work with pharmaceutical, biologics, and medical device manufacturers and clinical trial sponsors on assignments related to generating and demonstrating clinical data. 💡

➡️ Apply by 22 June 2025: https://eu1.hubs.ly/H0kNzqS0

Questions? Contact CRA Manager Eva Taliveer Hedin, and she’ll be happy to help!

21/05/2025

Our EQA team is attending the 26th IFCC-EFLM EuroMedLab Congress in Brussels! 🔬

We’re excited to present two e-posters based on fresh data from our latest external quality assessment (EQA) rounds:

💡 PO194 – Human Expertise vs. AI in Histopathology
Our EQA Director, Jonna Pelanti (pictured), compares participant results from a visual image GG analysis with two different AI algorithm outcomes.

💡 PO113 – Enhancing Pipetting Quality with EQA
EQA Solutions Manager, Kristel Virtanen (pictured), showcases insights from our 2024 EQA program focused on pipette performance and monitoring.

You can view both posters digitally throughout the congress. And if you're attending, stop by our booth to meet the team – including EQA Coordinator Teija Häkkinen (pictured), Sales Team Juha Wahlstedt and Jukka Korhonen, and Labquality Days Project Manager Miia Kämppi.