MY | ISO 14971:2019 Risk Management in Medical Devices

Language : English

Please choose a date from the options below					Please choose a date from the options below	Location	Price
On demand Klang Valley	Klang Valley		Book

This course is designed for individuals in the medical device industry who are involved in Regulatory, Quality, Design (including design changes), Development, Manufacturing, Marketing Managers and personnel decision makers on management system strategy and Internal Auditors

The training provides:

Identify the links between ISO 13485 (QMS) and ISO 14971 Risk Management
Understanding how risk management relates to the product lifecycle
understand how ISO 14971 applies to ISO 13485.
Define risk management terminology
Outline the stages of the risk management process
Define the key deliverables of the risk management process
Understand the latest updates of ISO 14971:2019

Content

Day 1:

Module 1: Overview of Risk Management

Definition of Risk
Links from ISO 14971 to ISO 13485, and Regulations
General Requirement for Risk Management
Phases of Risk Management

Module 2: Risk Management Process

Risk Analysis
Risk Evaluation
Risk Benefit Analysis
Risk Control
Evaluation of Overall Risk
Risk Management Review
Production and Post-Production Information

Module 3: Risk Management Tools

Understanding how and when in the lifecycle to use them
PFMEA, Fault Tree Analysis

Module 4: Creating Risk Management File

Minimal documentation

Day 2:

Module 5: ISO 14971:2019

Introduction
Terms & definitions
ISO 14971:2019 Overview of structure and contents
Current status

Auditors

Nur Khairun Hanis Abu Bakar

Moderator

A qualified auditor for ISO 9001:2015, ISO 13485:2016, GDPMD, MDSAP, and registered auditor with Malaysia Medical Device Authority (MDA) and Registered audit for social audit (SEDEX). She is also qualified trainer and accomplish the Train the Trainer organized by HRDF with collaboration with the training company. She holds the Degree in Chemistry Science from Universiti Sains Malaysia. She developed herself when start growing her career with local manufacturer in rubber industry. She currently extends her career as a Management System Auditor with a German largest certification body.