Maria Rickardsson Senior Quality and Regulatory Consultant
Maria has over 20 years of experience in regulatory frameworks, quality assurance and risk management gained from the medical device, software and telecom industries both in small start-ups and large international companies. She is a team player focused on deliver quality on time. With her long and broad experience, she easily grasps new issues and finds constructive solutions.
Specifically, Maria is supportive within ISO 13485, ISO 14971 and IEC 62304. Maria holds a masters degree in Electrical Engineering from Chalmers University of Technology. In addition, Maria is a certified scrum master and an expert representative on various international standardization committees for medical device software and medical device IT networks (IEC 62304, IEC 82304, IEC 80002 series and IEC 80001 series)
“I have a great idea on a revolutionary Medical Device! When should I first consider regulatory and compliance scenarios?” ”Now! Get yourself an understanding of the demands so that they can be considered and included in the planning. To initially include the regulatory requirements will increase the chance of success. If you wait until the product is almost ready is a great risk having to redo parts and get caught up in time consuming procedures.”