Swedish Medtech Regulatory Summit
The Swedish Medtech Regulatory Summit is just around the corner — taking place on March 12th at ...
Category: Medical devices (2)
Introduction to ISO 15189:2022
Do you work with quality management in a medical laboratory? Don’t miss our ISO 15189:2022 online ...
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 ...
Breakthrough devices: Key insights from MDCG 2025-9 guidance
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2025-91 to streamline the ...
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, ...
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. ...