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. […]
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 […]
Conference: Medical Device Product Life Cycle
Join us in boosting MedTech knowledge together! On October 8 and 9th, 2024, Key2Compliance is delighted to once again host the highly appreciated Conference, “Medical Device Product Life Cycle”, this time in Stockholm! We’re honored to have four Notified Bodies joining us as featured speakers at our event: BSI, RISE, Intertek, and TÜV SÜD. Featuring […]
A detailed examination of Laboratory-Developed Tests (LDTs) and In-House Devices
Zahra MadijahnConsultant, Regulatory Affairs The Power of Precision Medicine Laboratory-developed tests (LDTs), generally known as in-house devices, play a crucial role in diagnostic laboratories worldwide. Although both in-house devices and LDTs are created and utilized within a healthcare facility, the term “LDT” is generally used in a more specific context to refer to tests made […]
Usability Documentation for Your Medical Device
Malin TruvéRegulatory Affairs consultant, Usability expert Are you about to perform a Usability evaluation for your medical device and are unsure of what usability documentation that are needed? There are three common mistakes that a lot of people make. This blog to help you avoid some of the pitfalls. The advice is based on fulfilment of […]
Navigating Medical Device Regulations – Insights from Our Danish Consultants
Cecilie Bengtsen, Mia Trustrup Larsen, and Nadia Ragnvald Caspersen Key2Compliance has in the past two years expanded its Nordic presence with a dedicated team of regulatory compliance consultants in Denmark. The expansion is timely, given the increasingly stringent compliance requirements for medical devices introduced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic […]
IEC 60601 – Meeting the Electrical Safety Standards of Medical Devices
Read and learn more about IEC 60601 and IEC 61010, and the factors you should consider when developing a regulatory-compliant medical device. Electrical devices are part of our everyday lives, and they are undoubtedly cornerstones of our society and technology – this applies to the industries of life sciences and medical technology as well. However, […]