Manager of quality management systems 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.
Course program

Duration

21 hours

Language

English/Ukrainian

Format

100% online

Objectives

The objective of the course «Manager of quality management systems for medical device manufacturers» (ISO 13485) is to prepare professionals capable of effectively implementing, maintaining, and continually improving a quality management system for medical device manufacturing in accordance with the requirements of ISO 13485.

The course is designed to develop practical skills in managing processes related to the design, production, quality control, traceability, and compliance of medical devices with applicable regulatory and international requirements.

Target audience

The course is intended for:

  • Quality managers and quality assurance specialists in the medical device industry;
  • Employees of organizations involved in the design, manufacture, distribution, or servicing of medical devices;
  • Heads of departments responsible for quality assurance and product compliance with regulatory requirements;
  • Regulatory Affairs and compliance professionals;
  • Personnel responsible for the implementation and maintenance of a quality management system in accordance with ISO 13485;
  • Internal auditors and management system coordinators;
  • Consultants specializing in quality management systems for the medical device sector;
  • Representatives of organizations preparing for certification or planning to enter international medical device markets;
  • Professionals seeking to acquire practical knowledge and professional competencies in medical device quality management.

The course is beneficial for both newcomers to the field and experienced professionals who wish to structure their knowledge and enhance their professional competence in accordance with international standards and regulatory requirements applicable to medical devices.

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