Who we are & History
Professional company with huge experience. We offer customized & pragmatic solutions with one mind set: our clients are partners, not customers.
I have more than 18 years experience in the MedTech industry, including development industry, and extensive knowledge of clinicalapplications of new technologies.
My expertise in regulatory and clinical affairs led to several successful clinical trials and
regulatory submissions in Europe and in the US.I am a seasoned subject matter expert in taking new products from R&D tothe medical market.My extensive international experience (Israel, USA, France) helps opening new territories and engineerinternational partnerships.
In the MedTech industry, I haveworked as Medical Director or VP Clinical and Regulatory for several companies such as UltraShape or MediGuide, (Now part of StJude Medical). I have been involved in board meetings, business strategy, due diligence processes and audits (M&A).
I also have experience as qualified Medical Reviewer on behalf of European Notified Bodies.
Under the new regulatory environment I have successfully helped numerous companies obtain CE MARK or renew their CE MARK when it was in jeopardy.
Sample achievement: took part in the development of the first percutaneous heart valves for PVT – I joined upon creation (Merged with Edwards Life science in 2004) which lead to publications.
DNA Consulting works in cooperation with experienced partners that are also qualified and certified and experienced auditors with NBs.
Experienced in Europe, USA, Canada, China and Korea.