Risk management integrated into the overall quality management is one of the main components for global medical device compliance. To meet the approval requirements for almost every regulated market a comprehensive implementation and documentation of a full risk management lifecycle has to be demonstrated. This course introduces the major components necessary to achieve global regulatory compliance and approvability. The main emphasis is on European and US regulation. A practical path to implanting a successful risk management system across different subsystems will be presented. The main issues covered are risk management, compliance with IEC60601-1, usability engineering and software risk management. The course is based on 20+ years of experience in the medical device industry and emphasizes practical implementation issues and not just theoretical background. If your company is developing devices for international markets this seminar will give you the information needed to design and document a globally acceptable design lifecycle.
Why you should attend: