Content
In the medical device industry, the implementation of the EU MDR is bringing the requirements of DIN EN ISO 13485 further into focus, particularly through its requirements for the selection of suppliers. Suppliers in this area are increasingly demanding that customers comply with the requirements of DIN EN ISO 13485 and, if necessary, even be certified according to this standard. This makes it easier for customers to provide evidence of valid production of raw or semi-finished parts using a quality management system suitable for the medical device sector.
The seminar provides an overview of the requirements of DIN EN ISO 13485 and the EU-MDR. The regulatory requirements for medical device manufacturers are discussed as well as the requirements and implementation of suppliers. In addition to setting up a quality management system and risk management, the focus of the seminar is on process validation. The steps necessary to establish efficient and at the same time audit-proof processes are dealt with in a practical manner.
Topic overview
- Basics and connections EU-MDR and DIN EN ISO 13485
- Structure of DIN EN ISO 13485
- Application of the risk-based approach – interfaces to ISO 14971
- Application of DIN EN ISO 13485 to suppliers in the medical device industry
- Applicable regulatory requirements and guidelines
- Importance of robust (manufacturing) processes
- Basics of practical and risk-based process validation
target group
Current and future suppliers in the medical device industry, employees from the areas of QM/QS as well as purchasing and supplier management, production managers, process and validation engineers.
Prior knowledge
Basic knowledge of quality management helpful.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
