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 […]
MDR Is Not Too Complex – The Importance of a Clear Clinical Strategy
Jeanette Demorney Senior Advisor, Clinical Development – GBA Key2Compliance One of the most common statements you hear in MedTech right now is that MDR is simply too complex. It is often described as bureaucratic, unpredictable, and overly demanding, particularly for small and mid-sized companies. For many, the regulation itself has become the explanation for why […]
Meet us at Park Annual #20 2025
We’re excited to share that we’ll be on site as a partner at Park Annual #20 in Gothenburg on November 26, 2025, hosted by Sahlgrenska Science Park. This year’s program focuses on “Next Generation – Precision Medicine,” bringing together innovators, researchers, and industry leaders to explore future technologies and the evolving healthcare landscape. Our colleagues […]
See us at MedTechDagen 25 September!
GBA Key2Compliance is proud to be a partner of MedTechdagen and we look forward to being on-site when the industry’s leading companies, researchers, and decision-makers gather to discuss the future of medical technology, innovations, and regulatory challenges. At the same time, Medtech Magazine is celebrating its 20th anniversary, making this event even more special. Take […]
Outsourcing Internal Audits in MedTech: Strategic Advantage or Regulatory Risk?
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource […]
Join our Workshop on Building Clinical Evidence for MedTech!
Join us for a hands-on morning session designed to support MedTech startups and scale-ups as they take their first steps toward clinical investigation. Whether you’re preparing for your first-in-human study or planning your clinical strategy, this event will help you avoid common pitfalls and focus on what really matters to succeed. You’ll hear from experienced […]
From Prototype to Patient – Building Clinical Evidence for Medical Devices
Save the date – A half-day event for MedTech startups and scale-ups preparing for clinical investigations We’re happy to invite you to a hands-on morning session focused on essential – and often overlooked – parts of the clinical development journey before CE-marking. What we’ll cover Early Clinical Strategy – What must be in place before […]
Join GBA Key2Compliance at GoCo’s Open House Event!
We’re thrilled to invite you to join us at GoCo Health Innovation City’s Open House event on May 13. For the second year in a row, the companies at GoCo are opening their doors to showcase the dynamic ecosystem we’re building together. You’re invited to take part – free of charge. Join us for a […]
GBA Key2Compliance at RAPS Euro Convergence 2025 in Brussels!
GBA Key2Compliance is excited to attend RAPS Euro Convergence 2025 in Brussels! Join us from May 13-16 for Europe’s most comprehensive regulatory affairs conference, focusing on the latest developments and topics in healthcare products across Europe and beyond. Visit us at Booth #5 Our team – Helena Dahlin, Director Quality Assurance & Regulatory Affairs, and […]