Heidi Naderi

Senior Medical Regulatory Consultant and Lecturer

A highly-experienced medical device regulatory specialist and EU MDR / IVDR expert, Heidi’s experience includes conducting technical documentation assessments (TDA) of Class II and Class III medical devices and managing conformity assessments, from initial application through to certification and ongoing surveillance activities, including EU MDR, EU IVDR, EN ISO 13485, EN ISO 14971, and MDSAP audits. Heidi's current role is as a Senior Medical Device Regulatory Consultant, undertaking a wide range of projects advising clients on regulatory strategies in relation to EU MDR, EN ISO 13485, EN ISO 14971, and other relevant international standards, as well as conducting technical and QMS audits to identify gaps in a client's regulatory approach and documentation. Heidi is also currently delivering a series of courses on medical device risk, clinical data and regulatory strategy, as well as being an External Partner for an EU Notified Body.

Talks About
#technical

Preferred Locations
#NorthAmerica