IVDR brings stricter regulations for In Vitro Diagnostic medical devices

In 2016, the European Commission decided to gradually introduce a new mandatory regulatory framework for IVDs: IVDR (In Vitro Diagnostic Medical Device Regulation). The new regulations will replace the old In Vitro Diagnostic Medical Devices Directive IVDD on May 26, 2022. We know that it can be overwhelming to get an understanding of the new […]

Vitalis 2022 – Join our presentation on the 17th of May

Are you a manufacturer of a medical device software and curious to know more about clinical evaluation? Then you should visit Scandinavia’s largest eHealth event, Vitalis 2022, next week and listen to Johanna Fugelstad presentation. She will talk about clinical evaluations and highlight some basic and important concepts of the process. Date: 17th of May Time: […]

Welcome to the team!

Exciting times at Key2Compliance as we continue to grow and welcome another three new team members! Please join us in welcoming Anna Sahlholm, Zahra Mavajian and Kristina Edner to our great team.   ANNA SAHLHOLM, Senior Consultant Clinical Development What will be your role at Key2Compliance? I will work in the team of clinical development […]

Susanne Søeborg new Country Manager for Key2Compliance in Denmark

Medtech and pharmaceutical consultants Key2Compliance opened an office in Denmark just over a month ago. Now, the Danish business has got a new Country Manager. ”I look forward to helping Danish companies get their products on the market,” said Susanne Søeborg. Susanne Søeborg has extensive experience from the medtech sector. She has a master’s degree […]

MVA Boost Seminar – From idea to success

–  Join our Boost Seminar together with Medicon Valley Alliance in Copenhagen There are a large number of new start-ups in Medical Device and In Vitro Diagnostics in the Medicon Valley area. This seminar will focus on how a start-up in Medical Device or In Vitro Diagnostic can accelerate the development from idea to success […]