Principal
CurrentSole proprietor of medical device consulting firm specializing in the following:• Global quality system development, implementation and assessment.• Global medical device product registrations (US, EU, Canada, Brazil, China, Japan, Korea, Russia and numerous other jurisdictions in Latin America and Asia).• Training on quality system regulations (US, EU, Canada, Brazil, China, Japan, Korea and Russia), MDSAP and EUMDR.• Global quality system audits in support of client quality systems as well as on-site support in preparation, assessment and CAPA phases relating to regulator audits.• Client assistance during third party/regulator audits, inspections and assessments.• Client assistance in registration dossier preparation.