Risk Management is one of the primary requirements for demonstrating compliance and conformance to Quality Management system requirements as per ISO 13485 Standard for Medical Device and In-vitro Diagnostic device manufacturers. While analysing the reasons for the product failures often leads to inadequacy in understanding and implementing risk management in the organisation. This training is to create awareness of requirements and to have a better understanding.
• Introduction to ISO 14971:2019
• Links to regulatory requirements
• Understanding pf ISO 14971:2019 standard and implementation
• General requirements for risk management system
• Risk analysis
• Risk evaluation
• Evaluation of overall residual risk
• Risk management review
• Production and post-production activities
• Application of risk management in QMS
• Exercise
• Online Examination
02 Days
• Product Risk Managers
• Quality Assurance
• Regulatory Affairs
• Research & Development
• Project Managers
• Operations Managers
• Manufacturing Managers
• Engineers
The Application of Risk Management for Medical Devices based on ISO 14971:2019 Certification can be obtained by enrolling and attending our instructor-led training program. Post-completion of the course, participants are required to attend an examination containing multiple-choice questions to obtain the certificate. Participants scoring as per the passing criteria would be awarded a successful completion certificate by TÜV SÜD South Asia.
• Exam Type: Multiple choice questions
• Exam Questions: 50
• Exam Time: 75 minutes
• Required number of points: 30 points
• Maximum number of points: 50
• Aids: Open Book
• Passing Criteria: 60%
For more details, get in touch with us at [email protected]
