Upcoming webinar: what IVDR Article 5(5) means for your lab
The EU In Vitro Diagnostic Regulation (IVDR) is transforming how clinical laboratories develop, ...
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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 ...
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 ...
Strategic considerations for a successful 510k Submission 3
In the third part of our article series on the FDA’s new “radical transparency” initiative, we ...
The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device ...
Navigate the potential impact of radical transparency
In the second part of our article series on the FDA’s new “radical transparency” initiative, we ...