Regulatory Insights Breakfast: Navigating Lægemiddelstyrelsen’s Supplier Management Expectations in 2024
Did you know that Lægemiddelstyrelsen will prioritize Supplier Management in their inspections in 2024? Join us at Symbion in Copenhagen on the 15th of May. We’ve put together this unique breakfast to give you a quick introduction to what their expectations will be from a regulatory point of view and what questions you should be […]
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 […]
Utilising Clinical Strategy with Expert CRO Guidance from GBA Key2Compliance
With the complexity of medical device regulatory compliance today, having a well-thought-out clinical strategy can help make the process smoother. In a nutshell, clinical strategy refers to comprehensive planning and implementation of the clinical development process for medical device manufacturers. A well-conducted clinical strategy ultimately results in the approval of their product and its successful […]
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 […]
Upcoming FREE webinar: What about Change management?
🤔 What about Change management? Do you have a systematic approach to identifying, managing, and implementing changes to your products and company? Do you have a change system so complicated that you avoid using it and instead sneak changes past it hoping not to get caught? Or is it somewhere in between? 💡 Sign up […]
Join our upcoming FREE Breakfastclub webinar!
☕ Get your coffee ready on April 12th, 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 Emily Malmberg, PhD in the discussions about IVD Software – the road to IVDR compliance! Take the opportunity to listen to the experiences from the IVDR […]
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 […]
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 […]