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 Madijahn Consultant, 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 […]
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, […]
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 […]
Key2Compliance takes over long-standing sterilization training
The course Sterilization of Medical Devices has existed for over 30 years and hundreds of people have graduated from it. Now, Key2Compliance has acquired the course, which is the only one of its kind in the EU. ”We are extremely happy to be able to offer this unique and very successful course”, said Åse Ek […]
Understanding New Medical Device Regulations with Key2Compliance’s Clinical Development Experts
In recent years, regulations for medical devices have evolved significantly. The Medical Device Regulation (MDR) has been taken into effect, and in tandem, the In Vitro Diagnostic Medical Device Regulation (IVDR) has replaced the preceding IVDD. The new regulations MDR and IVDR, have elevated the level of requirements, adding emphasis on clinical evidence and a […]
Lisa Moloney from BSI – speaker at Biological and Clinical Evaluation Conference
We are happy to welcome Lisa Moloney, Principal Technical Specialist & Scheme Manager, Orthopaedics & Dental at BSI as speaker at the Biological and Clinical Evaluations Conference for Medical Devices on the 4-5th of October in Copenhagen. 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗼𝘃𝗲𝗿 𝘁𝗵𝗲 𝗹𝗶𝗳𝗲 𝗰𝘆𝗰𝗹𝗲 𝗼𝗳 𝗮 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 – 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝘁𝗼 𝗯𝗲 𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗲𝗱 The biological evaluation should address the […]
Speaker announcement: Biological and Clinical Evaluations Conference
We are delighted to welcome Sofia Segersson, Ina Schäffner and Danielle Giroud as speakers at the Biological and Clinical Evaluations Conference for Medical Devices on the 4-5th of October in Copenhagen. – How life improves when the gadgets improve Sofia Segersson, Entrepreneur, influencer, founder, Diabetesia.se – Getting your product to the market – how clinical […]