ISO 14971:2019 Risk Management for Medical Devices Training

Course Objective:

General requirements for risk management system
Risk analysis process, Risk evaluation process, Risk control and Evaluation of overall residual risk process
Step-by-step of Risk Management Process
Development of Risk Management File

Introduction to ISO 14971
Medical device classification
ISO 14971 Evolution
Overview of the Risk Management Process
Management Responsibilities
Competence of personnel
Hands-on development of a Risk Management Plan & Risk Management File
Practical activities to perform the Risk Analysis, Risk Evaluation, Risk Control and Evaluation of Overall Residual Risk
Risk Management Review
Production and Post-Production Activities

1 day or 2 days

Employee whom directly involved in the ISO 13485:2016 Quality Management Systems for Medical Device.

ISO 14971:2019 Risk Management for Medical Devices Training

Fill out the form below and we'll be in touch soon.

Name*

Email Address*

Contact No*

Please leave your message here

Security Challenge

	Phone Numbers	Email Address
	+6019-700 7250	contact@inspiring-training.com.my	Social Media