Description: Building an effective preventive system to reduce failures and operational risks of medical devices.
Content:
– Applying risk analysis methodologies (FMEA – HACCP).
– Preparing risk management files and monitoring implementation.
– Integrating risk management with the quality management system.
Learning Outcomes:
– Ability to design effective medical device safety programs.
– Enhanced control of operational risks and reduced device failures.
– Preparation for obtaining the accredited certification as a standards auditor.
Objectives: Promoting a culture of safety and technical risk management.
Target Audience: Biomedical engineers, quality engineers, heads of biomedical engineering departments, and hospital accreditation officers.
