Four Notified Bodies Headline the Medical Device Product Life Cycle Conference 2024

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 […]

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 […]