Dr. Arby Abtin

Overview: • Quality Specialist with extensive knowledge of quality management systems. • Former strategic Regulatory Affairs Manager with broad experience in the medical device sector. • Certified project manager (IPMA). • Certified quality auditor for ISO 13485 Quality Management System • Former scientist with more than 8 years of scientific research experience in the biomedical field. • Effective communicator, presenter, and team player.

Ensuring quality management system for regulatory requirements according to ISO 9001 &ISO13485 CE marking of medical devices according to Medical Device Directive 93/42/EEC Implementing and ensuring compliance with industry quality standards Preparing and conducting audit activities for external and internal audits Active support in implementing corrective and preventive actions Supervision and coordination of the change management process Claim management and risk analysis application