Senior Consultant at Key2Compliance AB
After almost 20 years in product development in the medical device field, working at different medical device companies in Sweden, Germany and Switzerland, Stina Gustafsson now focuses even more on the quality assurance and regulatory affairs parts. She has a great interest in medical device software and has experience from development of both mobile apps, stand-alone and embedded software.
Stina joined Key2Compliance 2018 and has since then been working with several medical device software manufacturers with the goal of regulatory compliance. Main assignments include, for example, technical documentation, risk management, building a QMS and qualification and classification of a device.