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...
Labquality Days 2026 Scientific Program Launched!
Welcome to the International Congress on Quality in Laboratory Medicine and Health Technology!
The FDA’s new transparency policy
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for...