CE-Marking

Sibylle Scholtz

Ph.D., biologist and chemist by education, has more than 18 years of experience in the field of medical devices as well as in the field of national and international medical device legislation - at Allergan Medical Optics (AMO) and Abbott Medical Optics. As “Manager Regulatory Affairs EMEA” at AMO she was responsible for several years for the registration process of all medical devices for AMO´s “Emerging Markets”. Moreover, she has been an active member in several working groups of EUCOMED, MECOMED and EUROMCONTACT, which contributed to her overall understanding and expertise in this field. Sibylle offers more than 22 years of experience in the ophthalmic medical device industry which resulted in high expertise and thorough understanding of developments, processes and future trends.

Myriam Becker

She has worked in the Medical Device industry for more than 15 years. For about 14 years she was responsible for Medical Device vigilance for Central and South Europe. From 2008 to 2012 she held the position of the deputy Medical Devices Safety Officer (Medizinproduktegesetz/Medical Devices Act § 30). In May 2012 Myriam moved to the Regulatory Affairs department at Abbott Medical Optics where she is responsible for “Regulatory Intelligence” and “review and approval of promotion and training materials” for the region Europe, Middle East and Africa. For more than 10 years she has been an Internal Auditor (Medical Devices); in December 2011 she additionally qualified as QMS Auditor/Lead Auditor (ISO13485:2003).

Stefan Menzl

Ph.D., serves as Director International Regulatory Affairs for Abbott Medical Optics (AMO). He is in charge of strategic planning, leadership and talent development for AMO´s International Regulatory Departments. Stefan currently manages all aspects of market access and product registration, regulatory compliance and relationship management with international regulatory governing bodies for AMO. In several regions he and his team are involved with obtaining reimbursement for AMO’s products. Stefan is a biologist by education and holds a Ph.D. in Microbiology and Biotechnology. He is an active member of the Regulatory Affairs Council of EUCOMED, a member of AdvaMed’s European Regulatory Working Group, the BVMed Working Group on Regulatory and Public Affairs (AKRP) and MECOMED’s Regulatory Working Group. He has been publishing numerous articles related to Regulatory matters.

Carsten Rupprath

Ph.D., is a chemist by education and holds a Ph.D. in Biotechnology. In 2007, Carsten started his career in the medical device industry as “Manager Regulatory Affairs Europe, Middle East, Africa” at Abbott Medical Optics (AMO) with the responsibility to register ophthalmological medical devices within the EMEA region. Since 2012, Carsten is in charge as “Director Regulatory Affairs” of a multinational team with the main tasks of product registration, market access and reimbursement of all AMO products within the EMEA region. He is an active member of the trade associations EUCOMED and EUROMCONTACT.