Quality Training

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)

Upcoming dates:

No training dates available at the moment.

Register your interest

Course

Medical Device Risk Management based on ISO 14971:2019 Foundation

Training Days

Course Access for 90 days

Training Location

Available nationally, based on demand

Course Cost

Member: €296
Non-member: €495
* Cost quoted per person

Register your interest