Implementation DIN EN ISO 13485 - Quality management for medical devices

GAB Europe
Quality Management, ISO Standards



The purpose of quality management is to create trust for the customer in the performance of a company. This trust is of particular importance when medical products are involved and consumers rely on the effectiveness of the medical products.

Acquire competence in the implementation of quality management for medical devices and comprehensive knowledge of the requirements of the standard DIN EN ISO 13485:2016. Through clear practical examples and exercises, you will learn about the special focuses, legal and regulatory requirements and advantages that this standard offers your company.

Trainer competence:

Several years of experience in the production of medical devices and projects for the implementation of DIN EN ISO 13485 in companies distinguish our trainers for this seminar.

Goal: Participants understand the specific requirements of DIN EN ISO 13485:2016 and are able to implement them successfully in their company.


o   Sense, purpose and advantages of quality management for medical devices

-       Requirements of interested parties

o   Identification of legal and regulatory framework conditions

-       European directives and medical devices law

-       Risk management according to DIN EN ISO 14971

·   Requirements for risk management and market monitoring

·   Required documented information

-       Placing medical devices on the market

-       Medical Device Safety Plan Ordinance

o   Requirements and implementation of a quality management for medical devices according to DIN EN ISO 13485:2016 and DIN EN ISO 9001:2015

o   Conformity assessment and declaration

o   Duties, rights and cooperation with consultants and security officers

o   Market monitoring and reporting system

o   Control of the processes by means of key figures

o   Organization of audit activities in the quality management system for medical devices

o   Evaluation of the effectiveness of the quality management system

o   Competence check or final examination

Requirements: none

Target group: Persons and managers who are involved in the production of medical devices and who want to introduce and implement a quality management system.

Duration: 5 days

Literature: Seminar documents and relevant legal texts

Price per participant open training:               2.600,00 EUR

Price per company internal event:                 16.500,00 EUR