Anki has almost 30 years of experience within QA and RA from several medical device and some pharmaceutical companies. Working as head of RA/QA as well as working directly with RA for supporting product development of medical device/IVD/combination products for EU and US.
Charlotte has more than 27 years of experience within the Pharmaceutical and Medical Device industries. The last 17 years as Pharma Regulatory Affairs expert, working with product registrations, building dossiers, Life Cycle Maintenance, Due Diligence and Regulatory strategies.
Karin has more than 17 years experience in Regulatory Affairs from several medical device companies, working with product development, CE-marking, registrations outside EU, medical device vigilance and Quality Assurance.