SME Profile

Mona Magnuson

Mona Magnuson has 31 years of experience in medical device quality and regulatory compliance. She has completed conformity assessments with three different notified bodies, Health Canada registrars, and, more recently, MDSAP. She is the owner of her own consulting firm and has participated in quarterly plenary notified body meetings in Brussels during the early years of MDD implementation.

Since 1998, Mona has been instructing medical device auditors at TÜV Product Service (now SÜD) and teaching public course offerings on ISO 13485 and European Directives with BSI, as well as private courses for medical device manufacturers concerning quality systems, internal auditor training, EU MDR, and MDSAP methodology and jurisdictions. 

11 years after participating in developing the initial curriculum for the International Regulatory Affairs course, Ms. Magnuson was a lead instructor for the Masters in Regulatory Affairs and International Regulatory Affairs courses at St. Cloud State University in Minnesota, USA.