AI in Medical Devices: Understanding the Review Process and Common Gaps
Free webinar with BSI and GBA Key2Compliance As artificial intelligence becomes increasingly integrated into medical devices, manufacturers face new challenges in demonstrating regulatory compliance. Understanding how AI is assessed, what notified bodies look for, and where common gaps arise is important when preparing for regulatory assessment. Join GBA Key2Compliance and BSI for a free webinar where […]
Free webinar: Quality Risk Management & Root Cause Investigations
22 October 2026 | 15:00 Swedish time | Online How do you get beyond assumptions when investigating a problem or assessing a risk? Join James Vesper, one of our expert course instructors, for a free introduction to our upcoming three-day workshop for the pharmaceutical and medical device industries. He’ll explore how investigations look backwards while […]
Webinar – Is your AI software a medical device?
Artificial Intelligence is transforming healthcare, but determining whether your AI solution qualifies as a medical device can be challenging. Join our free upcoming webinar to gain a clearer understanding of the regulatory landscape for AI-based software. We will explore qualification and classification under medical device regulations, applicable laws and standards, and the pathway to market. […]
SEMINAR – Medtech or Healthtech? Classification, Funding, and Market Impact
MEDTECH NETWORK – MEDICON VALLEY ALLIANCE Where is the line between MedTech and HealthTech – and does it matter? We’re pleased to be part of the upcoming MVA Medtech Network event hosted by Medicon Valley Alliance on 25 August at Medeon Science Park in Malmö. As digital health solutions continue to evolve, the boundaries between […]
FREE WEBINAR – From Regulatory Strategy to Clinical Evidence for Medical Devices
A regulatory strategy defines the pathway that brings a medical device to market, from qualification and classification through to the planning of all activities required to demonstrate compliance. Building on this foundation, the clinical strategy determines how the evidence required to support the device is generated and documented. The integration of regulatory and clinical strategies is a key factor in guiding both development and business decisions, with a direct […]
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 […]
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 […]
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 […]