- Course Description
The two day course Introduction to ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, together with ISO 14971, Medical Devices – Application of Risk Management to medical devices, provides the insight and tooling to set up and maintain a Quality Management System on a risk based approach.
Learning Objectives On completion of the training, participants will be able to:
• Understand the scope and use of ISO 13485 as basis of Medical Device Regulations Worldwide
• Interpret the clauses of ISO 13485 in detail
• Role of and relation with risk management according ISO 14971
• How to set up, implement and maintain a Quality Management System Examination or testing During the course cases are used to verify the gained knowledge. A quiz is used to test the knowledge of ISO 13485 at the closing of the course.
An examination with multiple choice and open questions can be provided for upon request.
Program overview
• Environment of ISO 13485 in the Medical Device Industry
• Introduction of ISO 13485 and comparison with ISO 9001
• Process approach • Documentation of a Quality Management System
• Product realization
• Management of resources
• Risk management
• Evening program: case on risk analysis
• Documentation of a Quality Management System
• Responsibilities of Management • Measurement, Analysis and Improvement • Questions & Answers
• Evaluation of the course and Closing
Who should attend
• Senior Management
• Quality Managers and Regulatory Affairs Managers
• Internal and external Auditors
• Anyone involved with the implementation of the Standard ISO 13485 The number of participants is maximized to twelve to provide a stimulating and practical working environment.
Level
There is no prerequisite for this course but participants will benefit from a basic knowledge of the quality management systems, ISO 9001 or ISO 13485.
Duration
2 days, including refreshments, lunches, diner and overnight stay.
Training material Course notes are provided on a USB stick.
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