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 […]
Meet us at The MedTech Forum 2026 in Stockholm, May 11-13
We are pleased to announce that GBA Key2Compliance will be participating as an exhibitor at The MedTech Forum 2026, taking place on May 11 to 13 in Stockholm. The MedTech Forum is the largest health and medical technology industry conference in Europe and has been a key meeting point for the sector since 2007. The […]
White Paper on Photobiomodulation and Red-Light Therapy Market Access
GBA Key2Compliance has published a new white paper titled Photobiomodulation (PBM) Across Wellness and Red-Light Therapy Markets – From Product Definition to Scalable Market Access. The paper addresses the rapid growth of PBM-based red-light therapy products across wellness, performance, aesthetic and longevity markets, and the strategic challenges that emerge as these markets mature. Rather than […]
Åse Ek – Leading the Next Chapter of Training & Education at GBA Key2Compliance
Insights on medical device training, regulatory compliance and the future of learning in MedTech. With more than 20 years of experience from the Medical Device and Pharmaceutical industries, Åse Ek has built her career at the intersection of product development, quality and regulatory affairs. Today, she leads the Training & Education area at GBA Key2Compliance, a role that combines […]
Breakfast seminar – Right from the start, AI-based medical devices
April 14th, 08:00–10:30 at GoCo, Mölndal Curious about how to successfully develop and scale AI-based medical devices from the very beginning? Join us for a breakfast seminar where we bring together experts and peers to share insights, discuss real challenges, and explore practical approaches. With an incredible line-up of presenters, moderator, and panelists, and an […]
Regulatory summit 2026
We were pleased to take part in Regulatory Summit 2026, hosted by Swedish Medtech. The event brought together professionals from across the MedTech industry for insightful discussions on the latest developments in RA/QA and MDR. A special highlight for us was seeing our partner Pia Lanneberg on stage, presenting “Communication that makes a difference”, an […]
Timing is Everything: The Crucial Role of QMS in Your Medical Device Journey
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA/RA- GBA Key2Compliance For startups in the medical device sector, the timing of your Quality Management System (QMS) implementation can significantly influence your path to market and the submission of your technical file. While it may be tempting to focus solely on product development, integrating a QMS early […]