What is a MedTech CRO and how can it benefit your company?
Jeanette DemorneyDirector, Clinical Development – GBA Key2Compliance Ever wondered how a MedTech Contract Research Organization (CRO) like GBA Key2Compliance can streamline your journey in the medical device and In Vitro Diagnostic (IVD) landscape? Let’s dive into how our critical support during clinical evaluation and strategic development can propel your project towards success. Understanding the Terminology […]
GBA Key2Compliance supports BOHUS with comprehensive CRO services
GBA Key2Compliance Enhances Quality Assurance, Regulatory Compliance, and Clinical Investigation for BOHUS At GBA Key2Compliance, we take pride in our role as the primary CRO for BOHUS, a Swedish company dedicated to producing high-quality hyaluronic acid (HA) products. Specializing in ophthalmics, aesthetics, and orthopedics, BOHUS extends its market reach to over 60 countries in the […]
Meet our new head of HR – Andreas Kedestig
We are delighted to welcome Andreas Kedestig as our new Head of Human Resources (HR) at GBA Key2Compliance. During his first couple of weeks, we had the possibility to sit down with him for a few moments and get to know him more. We would like to share with all of you what we talked […]
FINAL CALL: Only 6 Days Left! Join us for the Medical Device Product Life Cycle Conference
Don’t miss our international conference tailored to navigating the complexities of medical device regulations and standards. Why Attend? Gain invaluable knowledge from top industry leaders who will simplify complex processes and provide essential tools for success. Whether you’re in Quality, Regulatory, Design & Development, Clinical/Performance Evaluations, or Post-Market Surveillance, this conference is essential for staying […]
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, […]