ISO 14971 Risk Analysis & FMEA for Medical Devices | AE | TÜV Rheinland

ISO 14971 Risk Analysis & FMEA for Medical Devices

Two-day interactive workshop to learn steps of risk management as per requirements of ISO 14971 Risk Analysis and …

Learn Risk Analysis, Failure Mode and Effects Analysis (FMEA) and Management for Medical Devices

1,575.00 Dh

excl. VAT 1,500.00 Dh

Overview

Product number: AE-TUV-ISRA-01
Duration (in days): 2
Format: Virtual Classroom
Degree: Certificate of Achievement
Language: English

Training dates

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Benefits

Conduct risk analysis and failure mode and effects analysis to identify hazards
Apply risk analysis methodologies to medical devices
Learn risk evaluation and risk control principles that affect decision making
identify design or process failures and opportunity for development
improved risk management

Target group

Program managers
product managers
quality managers
Design Engineers
Manufacturing Engineers
E&D Managers/Engineers
Quality Assurance Managers/Engineers
Management Representatives
Design Teams
Design Review Teams
Project Managers
Internal and External Auditors

Prerequisites

Knowledge of product design, development manufacturing
Knowledge of Basic quality assurance concept

Course topics

Expectations of the Food and Drug Administration(FDA) and the EU in applying risk analysis to medical devices
Risk management requirement and the purpose of ISO 14971
The application of ISO 14971 to medical devices
The application of risk analysis methodologies such as FMEA to medical devices
The principles of risk management planning in developing procedures and practices to analyze, evaluate and control risks.
sources of information and further development

Degree

Certificate of Completion