Join GBA Key2Compliance at Tema Renrum 2024 in Upplands Väsby!
We’re excited to share that GBA Key2Compliance will be attending Tema Renrum 2024 on November 26-27 in Upplands Väsby! For over 25 years, Tema Renrum has been the go-to event in the Nordics for cleanroom technology. Over two action-packed days, attendees will enjoy expert presentations, a bustling exhibition, and plenty of networking opportunities. Our experts, […]
GBA Key2Compliance assists Watson-Marlow Flexicon with QA Manager
“During a critical period for Flexicon, we received invaluable assistance from the consulting firm GBA Key2Compliance, as we were without a Quality Manager for three months. With her expertise, Nadia stepped in and handled everything from customer audits and complaints to inquiries from clients. This enabled us to maintain our high standards and ensure continuity […]
Proud Silver Sponsor at ATMP Sweden 2024 – Meet Us in Malmö!
We’re thrilled to announce that GBA Key2Compliance will be attending ATMP Sweden 2024 as a proud Silver Sponsor! Join us on November 25-26 in Malmö at Sweden’s premiere annual conference for ATMP stakeholders, ATMP Sweden, bringing together experts from pre-clinical research to reimbursement and standard of care. Our experts, Sara Falkenklint and Maria Axelsson, will […]
Device changes and how they may impact biocompatibility
Kristina FantDirector, Biological Safety – GBA Key2Compliance AB Medical devices will go through many changes throughout their product lifecycle, such as change of suppliers for raw materials, change of production site, or development in subsequent product generations where technical improvements are central. Impact on the biological safety Throughout these processes, it is crucial to not […]
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 […]