The Importance of a Quality Management System (QMS) for Your Medical Device
Pär NeidenströmSenior consultant, Medical Device QA Dalia RhmanProduct manager PRRC, Medical Device QA The purpose of this article is to highlight the crucial role of the quality management system (QMS) for medical devices. Mainly by maintaining and improving patient safety and the product quality of the medical devices that are manufactured today. Of course, a […]
Join Us at Our ‘Medical Device Product Life Cycle’ Conference: Putting Patients First with Henrik Eriksson
At Key2Compliance, we believe in the power of impactful storytelling! We’re thrilled to announce Henrik Eriksson, a dialysis patient with years of firsthand experience, as our esteemed opening speaker at our “Medical Device Product Life Cycle” Conference in October. Henrik Eriksson’s insights offer a unique perspective, setting the stage for a conference filled with inspiration […]
Webinar – Elevate your Career: Insights on progression within MedTech Quality Assurance
Join us for a live webinar exploring the many opportunities within Quality Assurance for MedTech Professionals, hosted by industry experts from Key2Compliance Whether you are just starting out or looking for mid-career progression, this webinar will equip you with practical strategies and actionable steps to support a successful career in MedTech Quality Assurance. You’ll have […]
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
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, […]
Clinical Insights Breakfast at Medicon Village: Navigating MedTech Challenges with Jeanette Demorney & Maria Lindgren
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 […]
Expanding Your Medical Device Markets Globally: Smart Growth
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 […]
Regulatory Insights Breakfast: Navigating Lægemiddelstyrelsen’s Supplier Management Expectations in 2024
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 […]
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 […]