May is off to an exciting start, with a lot happening across the medtech and life science space.
From MedtecLIVE 2026 kicking off today to upcoming conversations on Clinical AI and the fast-approaching IVDR 2026 deadline, this month brings both opportunities to connect and key regulatory milestones to keep in mind.
In this edition, we share where to meet us, highlight an upcoming Master Class, and take a closer look at the IVDR transition, along with insights from our latest article on the future of training and education. |
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Starting today, May 5, through May 7, we’ll be attending MedtecLIVE 2026 together with GBA Group MedTech Solutions. Our Senior Advisor, Claudia Dannehl, will be representing GBA Key2Compliance at the booth.
We’re looking forward to three inspiring days filled with meaningful conversations, new connections, and valuable insights, together with our colleagues across GBA Group. |
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GBA Key2Compliance will be exhibiting at The MedTech Forum 2026 in Stockholm, May 11 to 13 - Europe’s leading MedTech conference.
Visit us at stand 27 at Stockholm Waterfront Congress Centre, where Åse Ek and Oscar He will be on site to discuss how we support MedTech companies through consulting and training.
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We’re excited to share that we’re bringing together two leading voices in Clinical AI for an upcoming Master Class.
Oscar He and Maria de Matos will explore how AI is transforming healthcare, focusing on clinical implementation, regulatory frameworks, and real-world patient impact.
AI in healthcare is not just automation, it enables safe, compliant, and clinically validated solutions. Today, it already supports clinicians in interpreting complex data, reducing administrative burden, and improving decision-making in regulated environments.
In this Master Class, we’ll explore:
✔ Regulatory Compliance, navigating MDR/IVDR with a strategic mindset
✔ Quality Management, building systems that support innovation
✔ Clinical Validation Strategies, ensuring your AI holds up under the scrutiny of an audit
You’ll also get access to the Clinical AI Pathway Assistant and the opportunity to network with experts in the field.
If you’re working in healthtech, AI, QA/RA, or simply curious about the future of clinically robust AI in healthcare, this is one you won’t want to miss. Register before May 30th! |
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How do you make complex regulatory training both practical, relevant and future ready?
In our latest article, we meet Åse Ek, who is shaping the next chapter of training and education at GBA Key2Compliance. With deep experience across QA/RA and the medical device industry, she is helping bridge the gap between regulation, learning and real world application.
From evolving industry needs to more hands on, impactful learning formats, this is a look at how education in life science is changing.
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How far along is your IVDR transition? For many manufacturers of legacy IVD devices, the transition to IVDR is now reaching a critical stage. The 26 May 2026 deadline is approaching fast, and key requirements need to be well underway to maintain eligibility under the transitional provisions.
This includes, among other things, an IVDR-compliant QMS, submission to a Notified Body, and a signed agreement within the applicable timelines. With Notified Bodies still under significant capacity pressure, timing is becoming a decisive factor.
Delays in preparation may risk loss of eligibility to continue placing devices on the EU market under the legacy framework, potentially impacting supply continuity.
If you’re working through your IVDR transition and want to reduce risk or speed up the process push the button below. |
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