Join Us: The Medical Device Product Life Cycle Conference – 8-9 October
Don’t miss your chance to attend Key2Compliance international conference, tailored to help you navigate the intricate world of medical device regulations and standards. Gain valuable insights from industry leaders who will break down complex regulatory frameworks and share the tools you need to succeed. WHY ATTEND? If you’re involved in Quality or Regulatory Affairs, product […]
The New IVDR Timeline: The European Commission’s 2024 Proposal
Zahra MavajianRegulatory affairs consultant The European Commission has recently proposed an extension to the transition periods for certain In Vitro Diagnostic (IVD) devices. This proposal, published in January 2024, is a significant development in the field of medical devices and patient safety since it provides more time both to manufacturers and the notified bodies to […]
Join Us at NLS Days on September 18-19!
We’re excited to announce that GBA Key2Compliance will be attending NLS Days in Malmö next week. Visit us at booth B:07 to meet our team: Jan Hellqvist, Helena Dahlin, Jeanette Demorney, Terese Hedin, and Anders Jeppsson from GBA Key2Compliance, as well as Timo Lebold and Judith Richstein from GBA MDS. We look forward to connecting […]
Key2Compliance becomes GBA Key2Compliance
Press Release Stockholm, September 12, 2024 Key2Compliance, a leading consultancy and training company serving the Medtech, IVD and Pharmaceutical industries, is now taking the next step in its merger with the GBA Group by changing its name to GBA Key2Compliance. Earlier this year, Key2Compliance announced that they had officially become part of the GBA Group. […]
Exciting Speaker Announcement! Medical Device Product Life Cycle Conference
We are delighted to announce that Joel Ironstone will be speaking at our Medical Device Quality Assurance and Regulatory Affairs Conference on October 8-9 in Stockholm, Sweden! Joel Ironstone is a medical technology development expert with over 25 years of experience developing novel medical technologies. His experience includes technical development, regulatory approvals and the design […]
Top Speakers at the Medical Device Product Life Cycle Conference: October 8-9
Don’t miss our international conference designed to navigate the complexities of medical device regulations and standards. This is your chance to gain essential knowledge and insights from top industry leaders who will simplify complex processes and provide invaluable tools. Why Attend? Whether you’re a Quality or Regulatory specialist, involved in design and development, clinical/performance evaluations, […]
Announcing 3 more esteemed speakers for the Medical Device Product Life Cycle Conference
Join us on October 8-9 in Stockholm, Sweden for an international conference focused on mastering medical device regulations and standards. Our expert speakers will provide invaluable insights and tools to simplify the complexities of product safety and regulatory compliance. Dr. Madlon Timme, Senior Expert Biological Evaluation, and Dr. Kristina Then, Professional Customer Service from GBA […]
Don’t Miss Out! Register Now for Our October Conference on Medical Device Regulations in Stockholm
Don’t miss out on our upcoming Medical Device Product Life Cycle conference on October 8-9 in Stockholm, Sweden! Join us for an international event dedicated to navigating the complexities of medical device regulations and standards. Our speakers are industry leaders ready to equip you with essential knowledge and tools, making complex processes simpler. This is […]
We can be your Biocompatibility Department
Do you require biocompatibility support at irregular intervals, without the need for a full-time employee? Would you like access to field experts precisely when you need them? Then choose us as your long-term partner! Led by Kristina Fant, Director of Biological Safety, our team serves as the biocompatibility department for many clients, deeply familiar with […]
A warm welcome to our new employees
Say hello to our newest colleagues: Claudia Dannehl, Maria de Matos and Afifa Trad! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. CLAUDIA DANNEHL, Senior Regulatory Affairs Consultant What will be your role at GBA Key2Compliance? I will join […]