Manager of the quality management system for medical device manufacturers

(ISO 13485)

The course “Quality Management System Manager for Medical Device Manufacturers (ISO 13485)” is designed to train specialists responsible for implementing and maintaining quality management systems in accordance with ISO 13485.

Participants will gain knowledge about QMS components, including leadership, risk management, selecting an appropriate number of procedures required for QMS functionality, documentation, performance measurement, management review, and the continuous development and improvement of QMS.

Considering the specific requirements of ISO 13485, the course also covers:

  • Personnel, Equipment, and Facility Hygiene: Requirements for maintaining high hygiene standards to ensure the safety of medical devices.
  • Feedback System: Additional requirements for a feedback system to provide early warnings about quality-related issues.
  • Risk Management: Specialized methods for assessing and managing risks associated with medical device manufacturing.
  • Regulatory Requirements: Compliance with regulations and standards governing medical device manufacturing.

Duration

21 hours

Language

English/Ukrainian

Format

100% online

Objectives

• Understand the implementation principles of the QMS for medical device manufacturers in accordance with the requirements of ISO 13485

• Get a complete understanding of the concepts, approaches, methods and techniques necessary for effective management of the QMS

• Acquire knowledge in identifying risks and opportunities related to the QMS

• Understand the linkage between the QMS and meeting the requirements of various stakeholders of the organization

• Develop the knowledge and skills necessary to advise organizations on best practices of the quality management for medical device manufacturers

• Get information about the organization and carrying out an internal audit

• Understand the operation of the QMS in accordance with ISO 13485

• Improve the ability to analyze the internal and external environment of the organization and decision-making in the context of the quality management system for medical device manufacturers

Target audience

• Heads of departments

• Project managers and consultants who wish to become familiar with the process of implementing and functioning of the quality management system for medical device manufacturers

• Members of the QMS for medical device manufacturers implementation team at the enterprise

• Professionals who wish to gain in-depth knowledge of the QMS for medical device manufacturers

• Specialists involved in daily support of the QMS processes

• Students of specialized faculties

Document on completion

Certificate of the QMS manager for medical device manufacturers, listed in the SIC international register

Thematic plan

The course program includes:

1. «Quality management system for manufacturers of medical device (ISO 13485)» module

The program is designed for 21 hours, including time for studying theoretical material and taking tests.

Objectives

Module 1 Quality management system for manufacturers of medical device (ISO 13485)

Number of hours

 1

Introduction

1,5

 2

Scope

0,5

 3

Terms and definitions

3

4

Quality management system

2

 5

Management responsibility

2

 6

Resource management

2

 7

Product realization

6

 8

Measurement, analysis and improvement

3

 

Testing

1