Medical Device Risk Management based on ISO 14971:2019 Foundation
ObjectivesCQI & IRCA Certified Online & Self-Paced Medical Device Risk Management & ISO 14971:2019 Training Course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019.
Delivered by Comply Guru.
Content includesFormat & Duration:
On Demand Training (Self-Paced Learning – Anytime, Anywhere 24/7)
Course Access & Support:
Upon registering for this course, a Learner will be able to avail of the following:
· Course Access for 90-days
· Phone & Email Support (Virtual Instructor)
On completion, successful Learners will have the knowledge needed to:
· Explain the history, purpose and structure of ISO 14971 and its relationship to ISO 13485 and the EU & US FDA regulations
· Define the key terminology used throughout ISO 14971
· Describe the elements of an effective risk management process
· Describe the different techniques that support risk analysis
· Explain the requirements for updating the risk assessment based on information collected and reviewed
· Outline the role of ISO/TR 24971 in risk management
Who should attend
Design & Development personnel
Quality / Engineering / Technical / Production personnel
Internal / Lead / Supplier Auditors
Complete the online, self-paced course modules and obtain 70% or higher in the final assessment (MCQ-based Assessment)
No training dates available at the moment.