Attention Software developers! Is you software a medical device? Are you prepared for MDR? Key2Compliance specialize in guiding software companies through the complex process of CE certification. Join us at our stand at E-Sundhedsobservatoriet on the 11-12th of October and talk to our experts Susanne Søeborg and Cecilie Bengtsen. Whether you need assistance with the entire certification project […]
Come and meet us at Medicinteknikdagarna on October 9-11th! Visit our stand and have a chat with our experts Tomas Camnell and Helena Dahlin and learn more about Key2Compliance and how we make complex things easier for Medical Device and IVD companies. We hope to see you there! 📅 October 9-11th 📍BioClinum, Karolinska Sjukhuset, Stockholm
Rise and shine Medical Device Software manufacturers! Get your coffee ready and sign-up for to our upcoming FREE breakfast club WEBINAR on October 19th, at 09.00! Join a 30-minute discussion with our experts about the MDR Transition period – What impact will it have on Medical Device Software (MDSW)? In the beginning of 2023, EU […]
See the recording here >> Join our latest webinar on the 1st of June where our first speaker, Susanna Hellström, Consultant Clinical Development will present the role of the monitor in clinical studies. You will get a brief overview of the visits they perform and obstacles they can encounter working with a study. Kristina Edner, […]
This is a must-attend conference for all medical device professionals dealing with biological and/or clinical evaluations, Clinical operations, QA/RA Managers, R&D managers and CEO:s. This conference will address biological and clinical evaluations from a risk perspective through a mixture of presentations from standard developers, notified bodies, test houses and device manufacturers. The first day will […]
Optimal Regulatory and Design Development from Idea to Success of a Medical Device To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor […]
Kom och lär känna oss på Key2Compliance på vårt nya kontor i Göteborg! Vi bjuder på en fullspäckad eftermiddag med värdefulla insikter, praktiska tips och framtidsspaningar. Flytten till GoCo house är en spännande expansion som sätter ännu en Key2Compliance-nål på kartan. Detta vill vi såklart fira tillsammans med dig! Vi bjuder på bubbel, snittar och […]
Save the date for our 2-day international conference on the 4-5th of October in Copenhagen, Denmark. This conference will address biological and clinical evaluations from a risk perspective through a mixture of presentations from standard developers, notified bodies, test houses and device manufacturers. They will present case studies with hands on experience on how to […]
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 […]
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 […]
