Date: 7 May 2019
Location: Amsterdam area
Language: Presentations will be in English
For more information: firstname.lastname@example.org
The one-day course, ISO 13485:2016 - a comprehensive introduction, provides insight in the use of the Standard as the basis for a Quality Management System for Medical Device manufacturers.
During the course, key-concepts and requirements of ISO 13485 are discussed, reviewed and comparisons to business processes are made. Participants will gain an awareness of the contents and context of the Standard.
Note: this training can also be provided in-house for other organizations in the supply chain involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing or provision of associated activities. The contents will be adapted to the specific role(s) of that organization.
This training covers the key concepts like the risk-based approach and the important requirements of ISO 13485:2016. The training is a combination of gaining knowledge to understand the requirements and skills to translate this into a pragmatic approach for setting up and maintaining a Quality Management System for organizations in the Medical Device Industry.
- EU Medical Device Regulations – an Introduction
- Key changes w.r.t. ISO 13485:2003
- Process approach
- Risk-based approach
- Details of the ISO 13485:2016 requirements
- Transition and Timelines
- Approach to update the QMS
- Understand the purpose of the Medical Devices Directives/Medical Devices Regulations
- Understand the relation between MDD/MDR and ISO 13485
- Identify and understand the ISO 13485:2016
- Understand the “process approach”
- Understand the “risk-based approach”
- Identify QMS documentation requirements
- Identify management responsibilities
- Understand resource management requirements
- Understand product realization requirements
- Understand ”improvement processes"
Who should attend?
Senior management, Quality Assurance Managers, Internal auditors, anyone involved in the implementation and maintenance of a Quality Management System in the Medical Device Industry.