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 […]
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 […]
Free Tutorials on Medical Device Regulatory Compliance Now Available on our Website
Our tutorials on medical device regulatory compliance are now available and can be accessed for free by clicking this link. Startups and scale-ups with limited experience on medical device regulations can refer to these tutorials to develop an understanding of the concepts and apply them to their development and market process. Given the complexity of […]
Swedish Key2Compliance and Canadian Ironstone Product Development enter partnership
Medical device and pharmaceutical consultants Key2Compliance have signed a collaboration agreement with Canadian Ironstone Product Development. The agreement gives Key2Compliance a stronger offering in North America and Ironstone a stronger offering in Europe. Key2Compliance has several years of solid experience and competence in the European market, both in terms of medical devices, In Vitro Diagnostics, […]
Key2Compliance Collaborates with Uppsala Innovation Centre’s Knowledge Platform
We at Key2Compliance are happy to announce that we have formed a collaboration with Uppsala Innovation Centre (UIC), one of the leading business incubators in Sweden, to produce videos for its knowledge hub. We are honored to be given this opportunity to partner with UIC while sharing a common goal of providing start-ups and scale-ups […]