Mark your calendars for October 8 and 9th, because Key2Compliance is bringing back the fantastic conference, “Medical Device Product Life Cycle”, to Stockholm! This time we’re excited to let you know that we’ve got an exceptional lineup of speakers from four Notified Bodies: Sharmila Gardner, Technical Documentation Manager & Head of UK Approved Body, from Intertek […]
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, […]
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, […]
Are you looking to gain a better understanding of how to prepare for clinical investigations? After a successful event at Symbion in Copenhagen, we are now offering this unique opportunity in Sweden as well! 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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
🤔 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 […]
