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 ...
Category: Article
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 ...