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Taly Vider Cohen, BSc

Regulatory Affairs and IP Director
Regulatory Affairs and IP Director

In the past 10 years I have worked in several positions in the regulatory affairs area, in an IVD company.
I led several successful submissions both in Europe, USA (510(k)) and other jurisdictions such as China, Japan, Australia and others.
As part of my roles, I took part in preparing multiple CE submissions and CE technical files.

I am responsible for creating and implementing regulatory strategies for the company's products which are distributed worldwide, including cloud- based products, software and hardware products, all are in the IVD and medical devices fields.

In addition, I am leading a team that is responsible for regulatory compliance, as part of several certifications such as ISO 13485, ISO 27001 and the MDSAP program.

Disclosure information not submitted.

Presentation(s):