sitem-insel AG

Viky Verna

Co-Founder and VP at confinis Corp (US) - Senior Consultant at confinis ag and med-HF (Switzerland)



Modules

Medical Device Regulatory Affairs and Quality Assurance:


Biography

Co-Founder and VP at confinis Corp (US), and Senior Consultant at confinis ag and med-HF (Switzerland), providing regulatory affairs services to the medical device and pharmaceutical industries. Qualification supported by 10 years of experience in the field, including 6 years working at the US Food and Drug Administration (FDA - ORA and CDRH), and a solid education with a MS in Biomedical Engineering, MS in Pharmacy, Regulatory Affairs Certificate, and a Regulatory Affairs Certification (RAC Global). Driven by a keen interest, developed expertise in and acquired substantial knowledge on the US, EU, and global regulations of medical devices, pharmaceutical products, and combination products.