Roni Frankel
Senior QA Consultant
Roni Frankel M.Sc, MBA, has an extensive experience of over 17 years in establishing, improving, maintaining, and leading Quality Systems of Medical Device companies, according to regulatory and international quality standards. In her diverse roles, Roni setup, and improved quality systems to ensure certification and accreditation of ISO 13485:2016 and CE mark, as well as alignment with Canadian and European regulations. Roni is a certified Internal Auditor for ISO13485; MDSAP; 21 CFR Part 820 and had audited contract research organizations to ensure GLP requirements are met. Roni took a leading part in identifying gaps between the QMS and newly introduced standards and regulations (such as ISO 13485:2016, and MDSAP) as well as defining ways to close identified gaps to ensure QMS full compliance. Roni holds Cum Laude M.Sc. in Neurobiology from the Hebrew University, Jerusalem, and MBA from the Technion – Israel Institute of Technology.
