Representative for Quality Management in the Medical Device Industry according to ISO 13485:2016 - TÜV
You are already familiar with the standards and laws for implementing an effective quality management system at a medical device manufacturer. ISO 13485:2016 (in the version published in 2021 as DIN EN ISO) as an internationally recognized standard is the basis of your work in the medical technology world. You will be familiar with the link between the European Medical Device Regulations MDR and IVDR and the ISO standard and their importance for a continuously functioning QMS.
In the second 5-day module of our training course, you will acquire the qualification as a quality management representative in the medical device industry in accordance with ISO 13485:2016. This will expand your methodological and technical expertise and show you how you can implement your knowledge quickly and effectively in your company. As part of group work, you will learn how to set up, maintain, and continuously develop a QM system in the medical device industry in compliance with standards and legislation.
As a QM representative, you are the central point of contact for all matters relating to medical device quality management, not only internally for employees and management, but also for external bodies such as certification bodies/designated bodies and competent authorities.
An excellent add-on is an advanced qualification as a quality auditor, which you can acquire in the third part of this modular training course.
- Explain the function of the Quality Management Representative in the medical device industry according to ISO 13485:2016 in comparison to other quality-related roles in the company
- Process management and documentation systems:
- Core and support processes in a medical device company
- Corrective and Preventive Actions (CAPA process), Continuous Improvement Process (CIP)
- Monitoring of products on the market
- Communication with the authorities and notified bodies
- Operational implementation of ISO 13485:2016
- Supplier management
- Conformity assessment according to MDR/IVDR, (product) approvals
- Risk management in the medical device life cycle and the importance of the risk management standard ISO 14971
- Accreditation and certificationGroup work
- An examination is required as part of the training
- As a quality representative in the medical device industry according to ISO 13485:2016, you will be able to set up an innovative management system with the help of consistent process analysis and process optimization.
- You will deepen your knowledge of ISO 13485:2016/ Annex A 11:2021 and be able to implement it in a company-specific manner.
- You will expand your methodological and technical competence in quality management according to ISO 13485:2016.
Employees in the medical device industry and from suppliers who are actively involved in the quality management system and quality improvement
Certificate specialist for quality management in the medical device industry according to ISO 13485:2016 - TÜV (seminar no. 4611121)
- The number of participants is limited to 16.
- The seminar is the second module of the advanced training course Quality Management in the Medical Device Industry.
- The contents are explained using practical case studies and deepened in group work.
- The seminar is based on ISO 13485:2016 and is not DAkkS-accredited. There is no recognition for the modular training Quality Management and Quality Management in Healthcare and Social Services according to ISO 9001:2015.
English
certificate from the TÜV SÜD Akademie