European Medical Device Regulations

3rd June, 9 pm, Europe

3rd June, 11 pm, Middle East

4th June, 5 am, Sydney, Australia

Title: Overview of the European Medical Device Regulations

Bio: Gert is an expert in European regulations based on more than 25 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic, regulatory and business consultant. He has been leading the Notified Bodies in Brussels for many years and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic,

result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultant with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president of RAPS and serves as board member of RAPS Europe.

Title: Analysis of the Regulatory Challenges to Multinational Medical Devices and In Vitro Diagnostics Manufacturers in the Middle East North Africa (MENA) region

Bio: Ebrahim is originally from Syria but has been living in the United Arab Emirates since 2013 where he completed his undergrad in Biomedical Engineering at Ajman University. He is currently finishing his Master’s in Clinical Research Management & Regulatory Science at Arizona State University. He has been working in medical device regulatory affairs since 2018 where he worked with different organizations from regulatory consultancies to medical devices manufacturers handling a huge variety of medical devices from hospital hardware to hyaluronic acid based medical devices. Ebrahim also worked as an onsite ISO 13485 auditor for a conformity assessment body, auditing multiple organisations in UAE. His current position is regional regulatory affairs senior specialist for Roche Middle East where he is working with Roche diagnostics division.