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. […]
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 […]
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 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. […]
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, […]
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 […]
Speaker announcement: Medical Device Product Life Cycle Conference
Exciting Announcement! Meet three of our speakers for the Medical Device Product Life Cycle Conference Join us on October 8-9 in Stockholm, Sweden for our international conference dedicated to navigating medical device regulations and standards. Our expert speakers will share invaluable insights and tools to simplify complexities in product safety and regulatory compliance. 🔹 Judith […]
Fundamentals of the technical documentation
Anna SzczepkowskaConsultant, Medical Device QA Introduction Technical documentation, also known as technical file, is a set of the documents that contains all the technical information concerning a medical device. Therefore, every EU manufacturer of medical devices (regardless of risk class) must according to regulations create technical documentation. This must include clear information regarding design, manufacture, […]
Expanding Your Medical Device Markets Globally: Smart Growth
Joanna JacksonSenior consultant, Regulatory Affairs Julia SelmaniSenior consultant, Regulatory Affairs Many businesses aim to expand and diversify their medical device markets to generate additional revenue while spreading risk. Despite the global regulatory environment for medical devices being diverse and complex, opportunities for expansion exist. However, if managed incorrectly, this expansion can lead to costly administrative […]