Aurevia

Aurevia We are quality makers – a team of experienced experts in healthcare and health-tech quality.

Our quality services for the healthcare and medical technology industries cover external quality assessments, regulatory consulting, clinical research, audits and certifications, and training. Our expertise and knowledge benefit customers from medical device and in vitro diagnostic manufacturers to startups as well as healthcare units to clinical laboratories.

Planning to enter the U.S. medtech market?The rules are changing—and you need to be ready.📢 On February 2, 2026, the FDA...
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

Labquality Days turns 50 next year! ❄️Have you visited the congress during the last 50 years? What has been the most mem...
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

💡 How do you shape regulatory complexity into strategic clarity?As AI continues to reshape healthcare, clear guidance on...
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.

🔬 Join our upcoming webinar IVDR & In-House IVDs: What IVDR Article 5(5) Means for Your LabThe EU In Vitro Diagnostic Re...
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

We are delighted to welcome Prof. Tomáš Zima, President-elect of the European Federation of Clinical Chemistry and Labor...
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

We’re heading to MEDICA next week! 🌍 We’re excited to share that our team will be attending MEDICA 2025 in Düsseldorf — ...
12/11/2025

We’re heading to MEDICA next week! 🌍

We’re excited to share that our team will be attending MEDICA 2025 in Düsseldorf — one of the world’s largest medical trade fairs. It’s a fantastic opportunity to connect with innovators, explore cutting-edge healthcare technologies, and showcase how we’re contributing to the future of medtech and healthtech solutions.

📅 Date: 17-20 November
📍 Location: Düsseldorf, Germany
👉 Booth: Hall 15/E38

If you’re attending too, drop us a message or stop by our booth to say hi. We’d love to meet and exchange ideas with you!

Labquality Days turns 50! 🎉 Northern Europe’s leading congress on quality in laboratory medicine and health technology i...
03/11/2025

Labquality Days turns 50! 🎉 Northern Europe’s leading congress on quality in laboratory medicine and health technology is back on 5–6 February 2026. ❄️

New this year: Satellite Workshops on 4 February. Secure your place early, as there are limited seats available! The topics are:

🔬 Patient-Based Quality Control
💡 Clinical Investigation Design for Medical Devices

Super Early Bird rates are available until the end of November, so register now! 👉 https://eu1.hubs.ly/H0pfQ320

Global Health Exhibition - ملتقى الصحة العالمي provided our EQA Key Account Manager, Jukka Korhonen, with valuable insig...
31/10/2025

Global Health Exhibition - ملتقى الصحة العالمي provided our EQA Key Account Manager, Jukka Korhonen, with valuable insights for healthcare transformation in Saudi Arabia. 💡

He met healthcare authorities and representatives from Saudi laboratories and diagnostic companies at the world’s fastest-growing healthcare exhibition in Riyadh.

🔍 IVDR Reality Check: Are We Moving Fast Enough? As of February 2025, around 1,500 IVDR certificates have been issued. B...
30/10/2025

🔍 IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then the math just doesn’t add up.

📊 At the current pace, we might reach only ~7,500 certificates by 2029 — far short of what’s needed to keep all products on the market. To close the gap, the industry must scale up efforts 3–4X. That’s a serious challenge.

⏱️ Survey data shows:
• QMS certificates: 55% of notified bodies issue them in 6–12 months.
• QMS + Product certificates: 64% take 13–18 months, and 9% take up to 2 years.

Interestingly, 61% of the total certification time is spent with manufacturers, not notified bodies. That means the bottleneck is often internal — in documentation, technical files, and readiness.

As Ullastiina Hakala, Quality & Regulatory Affairs Expert at Aurevia, explains: “Navigating IVD regulations doesn’t have to be overwhelming. Our experts help manufacturers cut through the complexity — offering clear and actionable guidance to set you up for long-term success.”

⏳ There’s still time. But many IVD manufacturers may be thinking the same thing — and waiting could mean missing the window.

Read the full article and learn how we support IVD manufacturers: https://eu1.hubs.ly/H0pd3--0

We can help you stay ahead of the curve by supporting you with:
• Classification
• QMS compliance
• Performance evaluation
• Post-market surveillance
• Gap analysis & auditing
• Technical documentation
• Training

❄️ Get to know the Labquality Days 2026 opening keynote speaker! ❄️Dr Rob T.P. Jansen is one of Europe’s most influentia...
22/10/2025

❄️ Get to know the Labquality Days 2026 opening keynote speaker! ❄️

Dr Rob T.P. Jansen is one of Europe’s most influential voices in laboratory medicine. In his opening keynote lecture, he will reflect on 50 years of progress and offer a future-focused vision for EQA, big data, and patient-centred quality. 💡

Read more about Dr Jansen's impressive career and his keynote lecture 👉 https://eu1.hubs.ly/H0nTj9V0

Don’t miss this inspiring start to our anniversary congress! Get your tickets now at the Super Early Bird rates: https://eu1.hubs.ly/H0nTgdN0

🚧Is your QMS helping or hindering your organization?Sometimes the most burdensome Quality Management Systems (QMS) are t...
21/10/2025

🚧Is your QMS helping or hindering your organization?
Sometimes the most burdensome Quality Management Systems (QMS) are the ones that organizations have built up themselves. But why does this happen?

💡 Could it be a lack of understanding, trust, or collaboration? Or perhaps a disconnect between those who write the SOPs and those who live them?

Don’t miss our latest article by Ferenc Dahnér, Senior Quality & Regulatory Consultant at Aurevia, where he explores how a leadership mindset, employee involvement, and collaborative approach can transform a QMS from a bureaucratic burden into a strategic asset.

👉 https://eu1.hubs.ly/H0n-CXr0

Planning to enter the U.S. medtech market?The rules are changing—and you need to be ready.📢 On February 2, 2026, the FDA...
20/10/2025

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/H0n-k730

Osoite

Kumpulantie 15
Helsinki
00520

Aukioloajat

Maanantai 08:30 - 16:00
Tiistai 08:30 - 16:00
Keskiviikko 08:30 - 16:00
Torstai 08:30 - 16:00
Perjantai 08:30 - 16:00

Puhelin

+358985668200

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Kategoria

Integrated EQA service

Integrated EQA service is a completely new approach to external quality assessment. New programs integrate pre- and post-analytical EQA schemes to traditional analytical EQA providing a full support for ISO15189 standard requirements.

Labquality´s clinically relevant external quality assessment service programme includes more than 170 EQA schemes, covering the key specialities of laboratory medicine. Furthermore, the programme includes a wide range of products intended for point-of-care test sites. Currently more than 5500 laboratories and POCT sites all over the world use Labquality´s external quality assessment programs.

Read more: https://www.labquality.fi/en/external-quality-assessment/annual-eqa-programme/integrated-eqa-service/