It’s been an eventful spring – we’ve taken part in inspiring events like RAPS and GoCo Open House, welcomed new colleagues to our team, and shared fresh insights in our latest blog posts. Missed our popular webinar for Start-up companies? No worries - you can catch up and watch the full recording. Scroll down for all our latest updates and highlights.
We attended RAPS Euro Convergence 2025!
Earlier this month, GBA Key2Compliance had the pleasure of participating in RAPS Euro Convergence in Brussels.
Our experts Helena Dahlin and Jeanette Demorney were on site, sharing valuable insights on navigating regulatory challenges and accelerating Medtech projects.
A big thank you to everyone who stopped by - it was great to connect and discuss future collaborations!
GoCo Open House
In Gothenburg, we were at the GoCo Health Innovation City's Open House event! It was a fantastic day, offering a glimpse into one of Sweden’s fastest-growing innovation ecosystems.
We had a great time connecting with leaders in life science, and we're proud to be part of this dynamic community. On the photo you can see Johan Grahn with Dr. Claudia Einer from GBA Medical Device Services at our stand at GoCo.
IVDR Compliance Deadline – Are You Prepared?
The IVDR deadline is here! Ensure your QMS is compliant and your IVDR application is submitted. For Class D IVD manufacturers, a Notified Body agreement is required by September 26, 2025.
Need assistance? Visit our website to learn how GBA Key2Compliance can help you stay compliant.
Camilla brings over 30 years of experience in the life sciences industry, with deep expertise in pharmaceuticals, medical devices, and consulting services.
Her professional journey spans executive leadership in established companies as well as advisory roles helping businesses navigate growth and transformation.
We're thrilled to introduce Evelina Greschner, Ana Zamani, and Susanne Glantz to the GBA Key2Compliance team! Each of them brings valuable expertise and passion to help us continue simplifying complex challenges—from idea to market. We look forward to growing together! Learn more about their roles and backgrounds here: Meet our new team members
Learn how to avoid pitfalls for Start-ups
In the MedTech industry, 8 out of 10 start-up companies don’t make it past their first 7 years. Why do so many fail, and how can you avoid the most common pitfalls? See full webinar by clicking the button below.
Our latest blog post by Johanna Fugelstad and Anna Sahlholm
Is your literature search just a checkbox or a strategic asset? Many manufacturers still treat structured literature searches as a one-time task, often performed late in the process. But when done right, it can be a powerful tool.
In clinical investigations, planning and coordination are everything.
Tight timelines, limited budgets, and regulatory requirements all have to align – without compromising on compliance or patient safety.
In the article, Anna explains: – Why planning, timelines, and protocol clarity are key to keeping studies on track – How strong site coordination and teamwork help overcome tight deadlines – What sponsors can do early on to avoid costly mistakes and delays
You’ll also get insight into how we work as a MedTech CRO – supporting clinical investigations from planning and coordination to approvals and follow-up.
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