Medical Device Risk Management based on ISO 14971:2019 Foundation

Objectives

CQI & 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 includes

Format & Duration:
On Demand Training (Self-Paced Learning – Anytime, Anywhere 24/7)
Duration: 8hrs

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)

Learning Objectives:
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
Regulatory affairs
Internal / Lead / Supplier Auditors

Qualification

Assessment Methodology:
Complete the online, self-paced course modules and obtain 70% or higher in the final assessment (MCQ-based Assessment)