Welcome to celebrate the 50th anniversary of the Labquality Days Congress!
In 2026, Labquality Days turns 50, and we want to celebrate this milestone together with you.
Category: News
Season's greetings
As we wrap up an incredible year, we want to express our heartfelt gratitude to our amazing...
Notice about a change in some of our email addresses
Please note that as part of the upcoming company split on 1 January 2026, some of our email domains...
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...
Fast track for mononational clinical trial applications in Sweden
Starting September 1, 2025, the Swedish Medical Products Agency (Läkemedelsverket) introduced a...
Upcoming webinar: what IVDR Article 5(5) means for your lab
The EU In Vitro Diagnostic Regulation (IVDR) is transforming how clinical laboratories develop,...
IVDR reality check: are we moving fast enough?
As of February 2025, approximately 1,500 IVDR certificates have been issued. That’s progress — but...
Could your overly burdensome QMS be the organization's own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth....
FDA’s new guidance: Computer Software Assurance (CSA) for production and quality system software
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System...
Strategic clarity: The new currency in life science
In an industry shaped by rapid regulatory changes and global competition, leading life science...
The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device...
The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we...