Specialist for Quality Management in the Medical Device Industry according to ISO 13485:2016 – TÜV
Medical Devices Training - Module 1
Regulations in the medical device industry require medical device manufacturers worldwide to implement an effective quality management system. ISO 13485:2016 - or the German version of this standard, which will be published in 2021 as EN ISO - is an international standard that is recognised in almost every country in the world. The two annexes ZA and ZB of the German and European standard are linked to the key legislation in Europe - the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) - and provide an overview of where ISO 13485 covers the legal requirements.
Successful implementation of this standard is only possible with a well-trained medical device quality management staff. Investing in this training will provide real added value and ensure acceptance within your organisation.
Our 5-day training course for medical device quality management professionals according to ISO 13485:2016 will familiarise you with the regulatory principles of medical device quality management. You will become familiar with the regulatory environment of the current MDR/IVDR in which the standard is embedded. We will show you how to meet the requirements of ISO 13485:2016. We will present the structure, content, scope and exemptions of ISO 13485 and provide you with the knowledge you need to successfully support the QM system. You will learn the steps you need to take to process and document your medical device from inception to launch. You will work in groups to develop solutions for the practical implementation of your quality management system.
The seminar is part of a modular training programme and forms the basis for the further qualification to become a Quality Management Representative (QMB) or a Quality Auditor. TÜV SÜD Akademie offers you tailor-made options for this.
This course is also offered in german.
Vorteile | Advantages
- As a quality specialist in the medical device industry, you are familiar with the basics of quality assurance according to ISO 13485:2016/Annex A 11:2021.
- You know the regulatory requirements according to ISO 13485:2016.
- Your specialist knowledge will enable you to contribute to the development and maintenance of a process-oriented quality management system in the medical technology industry in accordance with ISO 13485:2016.
Inhalte | Content
- Legal basis on the subject of quality management
- Structure, scope and area of application of EN ISO 13485:2016/Annex A11:2021
- Requirements for management systems, Quality-relevant roles in the company
- Process-oriented quality management based on the medical device life cycle
- Basics of general QM documentation, document control and archiving
- Basics of continuous improvement (CIP): processes, methods, tools
- Basics in the area of measurements and testing
- Process control in the medical device sector
- Requirements for measuring equipment management for medical devices/diagnostics
- Basic quality management methods and tools
- Group work
- An examination is required as part of the training
- Importance in the European conformity assessment procedure
- Context MDR/IVDR and ISO 13485:2016
- Meaning of process, process orientation, process description and process validation
- Statistical process control and validation
Abschluss | Degree
certificate from the TÜV SÜD Akademie
Zielgruppe | Target group
Employees in the medical device industry and from suppliers who are actively involved in the quality management system and quality improvement
Hinweis | Note
- The seminar is limited to 18 participants.
- The seminar is the first module of the continuing education program Quality Management in the Medical Device Industry.
- 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.
- The seminar price includes the standards book “Quality management and risk management for medical devices” (ISO 13485 and ISO 14971).
Duchführende Akademie | Executing Academy
All online dates of this event are organised by TÜV SÜD Akademie GmbH in Germany. The General Terms and Conditions and examination regulations as well as the data protection information of TÜV SÜD Akademie GmbH therefore also apply to online training courses. If you have any questions, please do not hesitate to contact us at [email protected].