Unlocking the future of medtech
Navigating the European medtech regulatory jungle? Good news—real progress is ahead. In her latest ...
Takeaways from Labquality Days 2026
The Developing Healthtech track at this year’s Labquality Days was both energizing and ...
Finland accelerates CTA timelines
Finland is taking an important step forward in clinical research by accelerating timelines for ...
Breakthrough devices: Key insights from MDCG 2025-9 guidance
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2025-91 to streamline the ...
Season's greetings
As we wrap up an incredible year, we want to express our heartfelt gratitude to our amazing ...
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 ...
Upcoming webinar: what IVDR Article 5(5) means for your lab
The EU In Vitro Diagnostic Regulation (IVDR) is transforming how clinical laboratories develop, ...
Fast track for mononational clinical trial applications in Sweden
Starting September 1, 2025, the Swedish Medical Products Agency (Läkemedelsverket) introduced a ...
IVDR reality check: are we moving fast enough?
As of February 2025, approximately 1,500 IVDR certificates have been issued. That’s progress — but ...