Training for Sterilization Validation and Regulatory Compliance in Oct
Can you prove that a Medical Device is truly sterile? A medical device is ready for launch. The design has been finalized, testing completed, and documentation approved. Months, perhaps years, of work have led to this moment. But before the product reaches a patient, one critical question remains: How do you prove that it is […]
Nationella medicinska informationssystem (NMI)
Regulatoriska krav, praktiska utmaningar och vägen till regelefterlevnad Nationella medicinska informationssystem (NMI) är en grundpelare i Sveriges digitala hälso‑ och sjukvård. Dessa system möjliggör hantering, delning och långsiktig tillgänglighet av medicinsk information som är direkt relevant för patientvård på nationell, regional eller kommunal nivå. Mot bakgrund av deras betydelse omfattas NMI av ett särskilt svenskt regelverk: […]
Meet us at GoCo Open House 20 may 2026!
We are excited to announce that we will be participating in GoCo Open House 2026 at GoCo Health Innovation City. For one day, the doors open to the life science ecosystem at GoCo, bringing together companies, partners, and visitors to explore innovation, collaboration, and the future of healthcare. The event offers a unique opportunity to […]
IVDR – Critical Deadline for Legacy IVD Devices Approaching 2026
The transition to the EU In Vitro Diagnostic Regulation (IVDR) is now in its final and most critical phase. For manufacturers relying on transitional provisions for legacy IVD devices, the deadline of 26 May 2026 is rapidly approaching. This is no longer a distant regulatory milestone — it is an active compliance requirement that will determine […]