What data management really means in medtech and IVD
Most people underestimate what data management really means in medtech and IVD. In pharma, data ...
Category: Article
Germany strengthens medical data governance
Germany strengthens medical data governance – what it means for life science On 11 March 2026, the ...
What if some of the most influential systems in healthcare are the least regulated?
While MDR has placed high demands on medical device manufacturers, a new reality is emerging in ...
ISO 20417 – what device manufacturers should consider
The new edition of ISO 20417 has been published, further clarifying expectations for information ...
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969
A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969. The core message is ...
A big milestone for the MINT study
After nearly four years of coordinated, hands on work across sites and functions, the MINT study ...
Breakthrough devices: Key insights from MDCG 2025-9 guidance
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2025-91 to streamline the ...
Fast track for mononational clinical trial applications in Sweden
Starting September 1, 2025, the Swedish Medical Products Agency (Läkemedelsverket) introduced a ...
Strategic clarity: The new currency in life science
In an industry shaped by rapid regulatory changes and global competition, leading life science ...