Aurevia

01/12/2025

We’re excited to welcome Dr Tze Ping Loh, from the National University Hospital, Singapore, to Labquality Days 2026. ❄️

In his lecture, “Calibration is both therapy and cause of bias”, Dr Loh will explore how calibration practices can unintentionally introduce bias in lab measurements, and how tools like IQC, EQA and patient-based QC can help detect and manage it. 🔬

He will also host a hands-on workshop on patient-based quality control, offering practical guidance, an Excel tool, and expert insights on implementation.💡

“The workshop introduces what patient-based QC is, how to set it up, and how to run it routinely in the laboratory. It’s also a great opportunity to interact with several international experts in this area,” says Dr Loh.

Workshop seats are limited, so secure your spot soon when you register for the congress! 👉 https://eu1.hubs.ly/H0pSWwF0

28/11/2025

EVOLVE2CARE recently had the pleasure of speaking with Heikki Pitkänen, CEO & Founder of Lean Entries, for an insightful discussion on how regulatory literacy can empower innovation across Europe.

From how AI sandboxes and EDIHs can support compliance to practical tips for startups, their conversation is packed with valuable insights that show how innovation and regulation go hand in hand.

Don’t miss this opportunity to learn what regulatory literacy tools mean for innovators, startups, and the entire healthtech ecosystem.

👉 Read the full interview here: https://eu1.hubs.ly/H0q20by0

Home Europe’s innovators are full of ambition — but often struggle to navigate the maze of regulations that govern digital and health technologies. As new frameworks like the AI Act, Data Act, and European Health Data Space (EHDS) take shape, the need for clear, accessible, and practical regulat...

28/11/2025

Have you developed a new laboratory practice, tested an exciting device or achieved results that deserve visibility? 🔬

Present your insights and research at the Labquality Days ePoster exhibition! ❄️

The abstract submission deadline has been extended to 5 December 2025. Read more and submit your abstract 👉 https://eu1.hubs.ly/H0q1rP30

27/11/2025

We’re excited to welcome Erik Vollebregt back to Labquality Days! ❄️

A top EU legal expert in MDR, IVDR, the AI Act and broader life sciences regulation, Erik brings over 27 years of experience advising industry, governments, and EU institutions. Known for cutting through complexity, he’s a must-hear speaker for anyone navigating medtech compliance in Europe. 💡

➡️ Lecture: AI Act and MDR/IVDR 2026 Edition: Alignment therapy
➡️ Panel: Curing the System amidst Geopolitical Trade Wars: Regulatory Reform for Better Health and Innovation

Join us in Helsinki to hear how to align innovation with regulation in a shifting global landscape! 🌐

Scientific programme: https://eu1.hubs.ly/H0pXSQ20

26/11/2025

📢 Stay Ahead in Medtech Compliance!
Medtech is evolving fast — and so are the regulations that shape it. That’s why we have a dedicated LinkedIn channel called: Aurevia Medtech Compliance

Follow us to stay informed on:
✅ Regulatory updates
✅ Best practices in compliance and quality
✅ Insights and practical knowledge from our experts

Whether you're a manufacturer, innovator, or healthcare professional, visit our channel to get expert tips and strategies to support your product journey.

👉 Follow us and join the conversation: https://eu1.hubs.ly/H0p-1y30

25/11/2025

Don't miss our upcoming webinar!
IVDR & In-House IVDs: What IVDR Article 5(5) Means for Your Lab

The EU In Vitro Diagnostic Regulation (IVDR) is transforming how clinical laboratories develop, validate, and justify their in-house tests. With Article 5(5) now in effect, in-house IVDs are officially within the scope of regulatory requirements.
Join this informative webinar to find out what this shift means for clinical laboratories that have long depended on their own in-house developed methods.

📅 Topics will include:
✅ The scope and impact of IVDR and Article 5(5)
✅ The current status of IVDR implementation in 2025
✅ What Article 5(5) means in practice for clinical laboratories

Whether your lab is already working under Article 5(5), evaluating tests, or preparing for transition, this webinar will provide valuable insights to help you stay compliant.

📍Free, online webinar: Thursday, December 4th, 11.00-12.00 EET (UTC +2:00)
👉 Book your spot today: https://eu1.hubs.ly/H0pXDVc0

24/11/2025

Take advantage of the Super Early Bird rates and secure your spot at Labquality Days 2026! ❄️

The 50th Labquality Days congress is fast approaching – one of Northern Europe’s largest annual international events focusing on quality in laboratory medicine and health technology. 💡

🔹Register now: https://eu1.hubs.ly/H0pSXpN0

Got research or development work to share? There's still time to submit your abstract for the ePoster exhibition – the deadline is 30 November 2025.

🔹Learn more: https://eu1.hubs.ly/H0pSXbS0

20/11/2025

Planning to enter the U.S. medtech market?
The rules are changing—and you need to be ready.

📢 On February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) takes effect, replacing QSR 820. While the ISO 13485:2016 forms the backbone of the QMSR, additional FDA-specific requirements still apply.

Join our half-day online course to get a clear, practical overview of what this means for non-U.S. manufacturers seeking market access.

🧠 What you’ll learn:
• Overview of the QMSR
• Key differences between the QMSR and ISO 13485
• FDA-specific requirements that still apply
• Registration and post-market requirements

👥 Who should attend?
Professionals involved in medical device manufacturing, development, or improvement such as design engineers, quality engineers, quality/regulatory managers, etc.

🎯 After the course, you’ll have a solid understanding of the FDA’s QMSR, it’s relationship to ISO 13485, and a road map of the key areas to focus on for successful entry into the US market.

📅 Date: 3 December 2025
🕣 Time: 08:30–12:30 CET
🌐 Location: Online (in English)
💰 Price: SEK 3,900 (excl. VAT)
🎓 Led by Ferenc Dahnér, Senior Quality & Regulatory Consultant

👉 https://eu1.hubs.ly/H0pRdY60

19/11/2025

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/H0pH4ng0

18/11/2025

💡 How do you shape regulatory complexity into strategic clarity?
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data Act e-tool, the Finnish-Danish joint action has released an invaluable e-tool that sheds light on the European Health Data Space (EHDS) regulation.

The Entries EHDS Regulation e-tool is a free resource to support SMEs and public organizations in Europe, through the network of the European Digital Innovation Hubs (EDIHs), until the end of March 2026.

What is Lean Entries?
Lean Entries is the digital sandbox within its parent company Aurevia that transforms complex regulatory requirements into actionable knowledge. With over 20 years of experience in QA/RA, Heikki Pitkänen, CEO of Lean Entries and Senior Expert, Regulations & Quality at Aurevia, has helped hundreds of healthtech innovators — from medtech startups to AI developers — turn regulations into opportunity.

👉 Read the full article to learn how our e-tool sheds light on the EHDS Regulation: https://eu1.hubs.ly/H0pL3Vb0

Need urgent support?
At Aurevia, Heikki and our team of ca 100 experts in quality assurance, regulatory affairs and clinical research are here to support you with tailored guidance and hands-on expertise. Let’s discuss how we can help you transform regulatory complexity into strategic clarity so your organization can move ahead quickly to achieve your goals.

14/11/2025

🔬 Join our upcoming webinar
IVDR & In-House IVDs: What IVDR Article 5(5) Means for Your Lab

The EU In Vitro Diagnostic Regulation (IVDR) is transforming how clinical laboratories develop, validate, and justify their in-house tests. With Article 5(5) now in effect, in-house IVDs are officially within the scope of regulatory requirements.
Join this informative webinar to find out what this shift means for clinical laboratories that have long depended on their own in-house developed methods.

📅 Topics will include:
✅ The scope and impact of IVDR and Article 5(5)
✅ The current status of IVDR implementation in 2025
✅ What Article 5(5) means in practice for clinical laboratories

Whether your lab is already working under Article 5(5), evaluating tests, or preparing for transition, this webinar will provide valuable insights to help you stay compliant.

📍Free, online webinar: Thursday, December 4th, 11.00-12.00 EET (UTC +2:00)
👉 Book your spot today: https://eu1.hubs.ly/H0pF2dd0

13/11/2025

We are delighted to welcome Prof. Tomáš Zima, President-elect of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), to speak at Labquality Days 2026! ❄️

Prof. Zima will open the congress with a welcome address on behalf of EFLM and share his expertise in a lecture on the importance of quality control, accreditation and risk management as part of the scientific program.

Don’t miss this opportunity to hear from one of Europe’s leading voices in laboratory medicine! Read more in our blog: https://eu1.hubs.ly/H0py3wd0