Ny i rollen som RA – unik kurs i samarbete med Swedish Medtech
Vill du känna dig säkrare i din roll inom Regulatory Affairs? Tillsammans med Swedish Medtech erbjuder vi nu en unik möjlighet med kompetensutveckling för dig som är ny i din roll! Under kursen får du kunskaper om Regulatory Affairs i de olika stegen från produktidé till färdig produkt och eftermarknadskrav. Föreläsare är Åse Ek och Anna […]
Key2Compliance excels in QA Services
Key2Compliance can help companies in the pharmaceutical, medical device and in vitro diagnostic industry to avoid the pitfalls that regulatory requirements may present. With a strong offer in Quality Assurance, Key2Compliance can help clients reach the next level – all the way from development to commercial phase. For individual innovators or SMEs, it can be […]
Meet Anna-Karin Andermo – our new QA Manager
Key2Compliance continues to grow, and the person that will ensure evolvement and improvement of our Quality Management System, QMS, is Anna-Karin Andermo – our new Quality Manager. Anna-Karin is already a familiar face at Key2Compliance where she has been active as senior regulatory affairs consultant for several years, helping our customers fulfilling regulations and making […]
Unique project brings GMP education to the ATMP-area through VR- and on-demand training
Advanced therapy medicinal products (ATMPs) based on genes, tissues or cells offer revolutionary new opportunities for treatments of disease and injury. One of the challenges with ATMPs is that Good Manufacturing Practice (GMP) is necessary to ensure control and safety as research transitions to production. However, since the new manufacturing processes for ATMPs often are […]
3 keys to a compliant QMS for startups
Effective Quality management can be a challenge, both when you are just getting started and while you are expanding or progressing to a new phase in development. What are the requirements for the QMS? How much is enough? Who can help us with this? Key2Compliance’s Pharma QA team are experts on this. We provide services […]
Meet us at WINN, 10-11 november
Join us at WHINN – Week of Health and Innovation – on the 10-11th of November in Odense and get new knowledge, inspiration, and insight into the latest research, technology, and international trends. Meet our Danish Country Manager, Susanne Søeborg at our stand and learn more about Key2Compliance and how we make complex things easier for Medical Device, IVD […]
Thank you for attending our conference!
Key2Compliance this week hosted for the first time the Medical Device Product Life Cycle Conference, and we could not be any happier! Thanks to all the committed participants, speakers, and exhibitors for two fantastic days and for making this a success. Also thank you to our excellent moderator, Magnus Fyrfalk, who took on the task […]
Welcome to Our Newest Team Members!
Our team keeps growing! We are very happy to welcome our newest colleagues Johan Grahn, Jonas Jägerback and Lars Mentzer on board. They are joining forces with us to help continue doing what we love to do: make complex things easier – all the way from idea to market. JOHAN GRAHN, Senior Consultant Regulatory Affairs What […]
Time is running out – Join our conference!
We are beginning our countdown until our Medical Device Product Life Cycle Conference on October 26-27th! We are thrilled to see how many of you have signed up to join us. There are still some spaces left. If you haven’t yet registered, but are thinking about doing so, we encourage you to REGISTER NOW to […]
Meet Christoffer Ekström at the Medical Device Product Life Cycle conference
We are thrilled to announce that Christoffer Ekström, CEO at AI Medical Technology will one of the speakers at our conference “Medical Device Product Life Cycle” in October. 𝐅𝐫𝐨𝐦 𝐮𝐬𝐞𝐫 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 – 𝐚 𝐫𝐞𝐚𝐥 𝐰𝐨𝐫𝐥𝐝 𝐞𝐱𝐚𝐦𝐩𝐥𝐞 Christoffer will share his story on how AI Medical Technology matched a critical user need with innovative technology and […]