Johanna Fugelstad holds a PhD in Biotechnology from KTH Royal institute of technology, Sweden and a MSc in Molecular Biology from Stockholm University, Sweden.
Johanna is employed at Key2Compliance® and has more than 15 years’ experience from life science research and the medical device industry. Prior to working at Key2Compliance® Johanna has worked as a product developer for in vitro diagnostic point of care products for new-borns. She has worked with research, product development, production, quality and regulatory compliance for a variety of products including software as a medical device. Her main expertise lies within post market surveillance, risk management, clinical and performance evaluations.
Johanna’s role at Key2Compliance® is to provide consultancy services related to maintaining and developing technical files and related quality management processes, including post market surveillance, risk management, clinical and performance evaluation.