Regulatory requirements for the registration, Applicable legislation, Necessary documents, Appointing a Responsible Person, The portals, Registration numbers, Applicable deadlines.
*The webinar is recorded.
Bianca works within the Legal and VIP department dealing mostly with cosmetic and medical devices clients. She is following the legislative developments in these areas and advise on their impact and steps to be taken towards regulatory compliance.
- Over 33 years of service
- Helped 3,000 manufacturers from over 60 countries world
- Largest center in Europe for CE Marking, EC REP & EU Representative services
- Certified ISO 9001:2015 & ISO 13485:2016
- Our Team: Lawyers, Chemists, Pharmacists, and other Experts
- Member of EU Associations and EU Commission Working Groups
- Over 20 years of experience
- Working with the Israeli Ministry of Health, Notified Bodies in Europe, medical devices Manufacturing sites around the world
- Enable our customers to make their devices available on the Market whether in Israel or abroad.
- Organize annually conferences, courses, in the field of Medical Devices and compliance with the MDR&IVDR