GBA GROUP at MEDICA 2024
Meet our experts from GBA Key2Compliance, GBA MDS, and BAAT Medical at the upcoming MEDICA 2024, one of the largest medical B2B trade fairs in the world, from November 11th to November 14th in Düsseldorf, Germany. Join us in Hall 1 at booth 1D35 to explore new innovations and discuss how we can support your […]
The Importance of Establishing Safe and Efficient Sterilization Processes of Medical Devices
In the medical-device industry, sterilization refers to the process of eliminating forms of bacteria, viruses, fungi, as well as spores from medical devices and instruments. This step helps in ensuring that devices that come in contact with a patient’s body, during surgery or even during routine care, are free from microorganisms that may cause infections. […]
Research Use Only (RUO) vs. Device for Performance Study
Zahra MavajianRegulatory affairs specialist – GBA Key2Compliance AB Disclaimer: This article is provided for informational purposes only and should not be considered official text. Always check and follow applicable local rules and regulations. Startups in the medical device or in vitro diagnostic (IVD) sectors often face challenges in obtaining regulatory approvals quickly, whether it be […]
A warm welcome to our new employees
Say hello to our newest colleagues: Anna Östblom, Bernadette Lechner, Ida Björklund and Linda Rosén! They are joining us to help continue doing what we love to do: make complex things easier – all the way from idea to market. Anna Östblom, Clinical Consultant What will be your role at GBA Key2Compliance? I will join […]
The Important Role of a PRRC in Medical Device and Software Compliance
One of the changes introduced by the Medical Device Regulation (MDR) in 2017 and the In Vitro Diagnostic Device Regulation (IVDR), is the requirement of a designated Person Responsible for Regulatory Compliance (PRRC). A PRRC bears the important role mandated by the MDR and IVDR of maintaining the safety, integrity, quality, and effectiveness of medical devices. […]
Good Manufacturing Practice: Preparing for GMP Inspections and Addressing Common Challenges
Before going into the specifics of how pharmaceutical manufacturers can better navigate Good Manufacturing Practices (GMP) inspections, having a baseline understanding of GMP will help in properly preparing for inspections and avoiding common pitfalls. Simply put, GMP is a regulatory set of best practices that has been developed over time to ensure that products are […]
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 […]