We recommend this seminar if you would like to familiarize yourself with the contents of ISO 13485:2016 and options for its practical implementation. The medical devices standard ISO 13485:2016 has been issued. What are the key changes compared to ISO 13485:2012? What are the requirements for the quality management systems of medical device manufacturers? At the heart of ISO 13485:2016 is a comprehensive process risk management to be integrated in all medical device-related quality management processes of the company, including outsourced supplier processes. In addition to development and production, this includes processes that take place after the medical devices are placed on the market. Our two-day seminar will provide you with basic knowledge regarding ISO 13485:2016 and, as part of an implementation workshop, will explain in detail how to integrate the requirements for quality management systems in your company processes.
- Introduction to the legal and regulatory environment of ISO 13485:2016
- Legal environment (national and international) and regulatory framework
- Lifecycle of a medical device
- Classification of ISO 13485:2016
- ISO 13485:2016 in detail
- Process validation and risk analysis, documentation
- Qualification and infrastructure
- Development (design control, clinical data, validation)
- Vendor management
- Production management
- Continuous improvement process (CIP): internal errors, complaints, risks
- Corrective actions, preventive measures
- Corrective and Preventive Actions (CAPA), reporting process
- Deepening of the standard section in a practical workshop
Who should attend
- Medical device manufacturer and vendor personnel who will be involved in the launch of management systems or updating of the current management system
- Quality management officers (QMOs), product managers, Regulatory Affairs personnel
- Consultants in the medical device industry
Confirmation of participation TÜV SÜD Akademie
As a participant, you will receive a copy of the standards book "Quality Management and Risk Management for Medical Devices ISO 14971 and ISO 13485". If you already have sound knowledge of ISO 13485:2012, we recommend that you take the seminar “ISO 13485:2016 – What’s new?” (4611088).
TÜV SÜD Akademie senior expert trainers
- You will know how to introduce or optimize a management system in your company based on the new ISO 13485:2016.
- You will benefit from the extensive standards interpretation of ISO 13485:2016 by our experts.
- Through the group activities, you will gain certainty for the practical implementation of the requirements of ISO 13485:2016.
At present, there are no trainings/examinations scheduled in English language.
If you are interested, please contact us.