Quality Management Systems for Medical Device Manufacturers Regarding ISO 13485

Course Description

This course is certified by Exemplar Global.

One of the challenges in implementing an effective quality management system for medical devices is to effectively transfer the requirements of applicable standards to your own company. ISO 13485:2016 has a process-oriented structure and requires a process-oriented view of the company during implementation of a quality management system.

The seminar helps to understand the requirements of that standard and to derive the sensible implementation in your company. You know what you have to pay attention to when introducing or adapting the management system and know the success factors. You will acquire the necessary knowledge how to install a quality management system as a manufacturer of medical devices or as a supplier in the medical device industry. During the training, you will discuss a selection of main topics of ISO 13485:2016, including risk management, change management, software validation, extended requirements for development and market surveillance of medical devices, which will be more strongly weighted in Europe in the future.

Course Contents

Basics of implementation of management systems for manufacturers of medical devices 

• Overview of the current status of standardization
• Application and validity of ISO 13485:2016
• Link to international regulatory requirements
• Structure and content of ISO 13485:2016
• Key implementation aspects
• Documentation requirements
• Differences between ISO 9001:2015

Who Should Attend

This course is ideal for experts and executive personnel of medical device manufacturers and their suppliers that are involved in quality management system introduction, establishment and maintenance in the area of medical devices. Professionals in the medical device industry who want to gain a basic understanding of management systems and regulatory requirements.

Course Objectives

• You will acquire knowledge of the process-oriented standard ISO 13485:2016 regarding to management systems in the medical device industry.
• You will achieve a correct and efficient implementation of the ISO 13485:2016 standard in your company.
• You will optimize your company processes in the course of the introduction of a management system for medical devices.

Requirements

No requirements are necessary.

Methodology

This seminar addresses internationally valid standards. The contents of the seminar correspond to the current status of the revision/harmonization.This seminar could be chosen as single training but is also part of a modular qualification: After successful participation in the that modules, you could obtain the following recognized qualifications:

1. Regulatory Affairs Manager – TÜV (1^st module)

2. International Regulatory Affairs Manager – TÜV (2^nd module)