Lori White has over 10 years of medical device industry experience, primarily in global regulatory strategy and product approvals in Europe (CE Marking), Australia and New Zealand. Lori’s background includes: European Union medical device regulations, Therapeutic Goods Administration (Australia TGA), and Medsafe (New Zealand) regulations and device submissions; compilation of Technical Files for CE Marking; compilation of Clinical Evaluation Reports under EU MDR and MEDDEV 2.7/1 Rev. 4; developing global regulatory strategies; global medical device classification assessments; and performing international regulatory research.
Lori White - United States
Senior Quality and Regulatory Affairs Consultant
Lori White has over 10 years of medical device industry experience, primarily in global regulatory strategy and product approvals in Europe.
