A warm welcome to our two new team members!

We are glad to share with you that our Key2Compliance team has recently been joined by two new team members – Erik and Susanna. We are excited to introduce you to these two talented additions to our team! ERIK BOM, Medical Device QA/RA Consultant What will be your role at Key2Compliance? I will work as […]

Key2Compliance establishes office in Denmark

Medtech and Pharmaceutical consultants Key2Compliance are now expanding outside Sweden’s borders for the first time. Recruitment has already started for the Danish office in Copenhagen. ”We already have a number of Danish customers and have completed numerous courses and training there. This was a natural step”, said CEO Jan Hellqvist. Key2Compliance has greatly expanded its […]

Free webinar: Is your medical device software MDR ready?

There are lots of great ideas and products related to medical device software today. Many of them already are compliant to the Medical Devices Directive (MDD), others are in an earlier development state. Since May 26th, 2021, the Medical Devices Regulation (MDR) is in force and latest May 26th, 2024, all medical device software has […]

FREE Webinar – An overview of IEC 62304 Medical Device software

Join us for this free webinar January 25, 2021 • 14.00-14.20 CET Learn more about how you can comply with the IEC 62304 standard in your Medical Device software development and maintenance process. When to apply IEC 62304? Overall development process for a medical device that is or includes Software Main points of IEC 62304 […]