Successful internationalization of Key2Compliance As a consultant for Quality and Regulatory Affairs, Claudia Dannehl is our cornerstone for successfully advising medical device manufacturers in German-speaking countries. Get to know her now in our interesting interview and make an appointment to talk to her about current challenges! What brings you to the GBA Group? I am the first colleague for Quality and Regulatory Affairs for the DACH region and work closely with colleagues from Key2Compliance in Sweden and Denmark. What background and experience do you have with medical devices? I studied physics and did my doctorate in biophysics. I then helped build up the QA/RA department in two medical technology start-ups. Before I joined the GBA Group, I worked as a QA/RA consultant at another Scandinavian company. Thus, I am familiar with both the regulatory requirements and the specific challenges that (young) medical technology companies face in Germany and Scandinavia. Additionally, I am an active member of the German Society for Quality (DGQ e.V.). There I am part of the Berlin regional committee and also co-organizer of the supra-regional exchange of experience on medical devices. Where do you see the greatest potential in integrating Key2Compliance into the GBA Group? Key2Compliance has an excellent network of experts. During my time with manufacturers, I would have appreciated the opportunity to obtain testing and documentation from a single sourceCompanies often fear that obtaining all services from a single source will be more expensive. However, by allowing colleagues at the service provider to coordinate with each other, the opposite is often the case. Do you have experience with biological assessments? Yes, I have written several biological assessments according to ISO 10993-1. From feedback on the submission of clinical studies, I know that biological evaluation is one of the most challenging topics for manufacturers, next to clinical evaluation, as it requires a deep understanding of the underlying processes. Toxicology is not something you can learn on the side. What topics are you particularly interested in? The exciting thing about medical devices is the variety - both in terms of products and the tasks that need to be mastered. QA/RA is more than just documentation, it's often like a puzzle with 5,000 pieces. It's fascinating to be able to look at each piece in detail. Incidentally, I also do this in my podcast, which I regularly publish with my co-host on all common platforms. The quickest way to find our 'medical product talk' is here: https://lnkd.in/ecwC9fvS #GBAGroup #Key2Compliance #medicaldevices #quality #international
Helena Dahlin
1mo
Claudia Dannehl We are happy to have you with us at Key2Compliance and in our regulatory team. Not only are you contributing with your great knowledge but also a fantastic spirit and energy.
Jan Hellqvist
1mo
I have worked with Claudia before and I am so happy that she wanted to join GBA Key2Compliance. Her competence span over Regulatory, QA, Clinical and Biological Safety. She is our first Consultant in Germany and our aspiration is to focus on our expansion in Germany during next year both with consultancy services and Training. A warm welcome Claudia!!
Malin Borg
4w
So happy to have you in the team!
Managing Director bei GBA Medical Device Services GmbH
1moDelighted to have you on board, Claudia Dannehl- very interesting interview! The development of Key2Compliance is impressive. Your advice on Quality and Regulatory Affairs is of great value to our customer base in German-speaking countries. All the best to you and your first projects!