FDA goes 13485 – say hello to QMSR!
Finally! On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016. Medical devices – Quality management systems The final decision was presented four years after […]
2024 To-Do list for legacy devices transitioning to MDR
The European Commission published Regulation (EU) 2023/607 in early 2023 which specifies conditions for extending the deadlines for medical device manufacturers transitioning from MDD to MDR and removing the “sell off” period. The regulation was published to minimize impact on healthcare services caused by device shortage, to prevent unnecessary disposal of safe devices and to […]
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, […]
Aligning clinical evidence and market access for you medical device
Join us on the 21st of March in Lund, when Key2Compliance will host the Medtech Network, organized by Medicon Valley Allicance. The manufacturer´s focus during the medical device life-cycle is to continuously ensure safety and performance of the device, this is done by iterating/updating the technical documents such as the clinical evaluation and risk management […]
Join our unique Breakfast Event!
🔬 Are you looking to gain a better understanding of how to prepare for clinical investigations? We’ve put together this unique breakfast tailored to the challenges of clinical investigations in the MedTech sector. Join our experts Maria Lindgren and Jeanette Demorney as they explore and discuss essential topics related to this specialized field. This event provides you with a […]
Medical Device Product Life Cycle – Boosting medtech knowledge together!
SAVE THE DATE Join our Medical Device Quality Assurance and Regulatory Affairs conference on the 8-9th of October in Stockholm, Sweden. This is an international conference focused on navigating the world of medical device regulations and standards. Our speakers will share their knowledge and tools to help you make complex things easier! We will outline […]
Join our upcoming FREE Breakfastclub webinar!
☕ Get your coffee ready on February 2nd, 9.00 – 9.30 and take part in another one of our FREE knowledge sharing Breakfast Club Webinars! Welcome to join our experts Stina Gustafsson and Malin Borg in the discussions about EU Artificial Intelligence (AI) Act and Medical Device Software! 🤖 December 9th 2023, the Council and the European Parliament reached a […]
Building a Stronger Future: Key2Compliance becomes part of GBA Group through acquisition
Hamburg/Stockholm, 16th January 2024. With the acquisition of the Swedish company Key2Compliance AB (Key2Compliance), GBA Group is expanding its range of consulting and training services for the medical device, In Vitro Diagnostics (IVD), and pharmaceutical industry. GBA Group is thus taking another important step towards establishing itself as a broad service provider for international customers […]
Borderline Medical Devices
Olivia SunSenior Consultant Regulatory Affairs Have you ever been unsure of whether or not the device you are working with is a medical device? Don’t worry, most of us have. Medical devices are based on a wide spectrum of technologies. In fact, there are about 2 million different kinds of medical devices on the world […]