Join our breakfast event tailored to address the different approaches and best practices in supplier control

Are you seeking to learn more about how to ensure effective supplier control and outsourcing of processes, and which control strategies you can apply? Join us for an exclusive breakfast session tailored to address the different approaches and best practices in supplier control! Our experts Åsa Möllby, Director of Medical Device QA, and Oscar He, Product manager and Senior Consultant, […]

Fundamentals of the technical documentation

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

Expanding Your Medical Device Markets Globally

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

Medical Device Product Life Cycle Conference

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 Key2Compliance

Clinical strategy

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 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 […]

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 […]

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