content
In quality assurance agreements (QSV), the tasks between manufacturer and supplier, service provider or (triggered by the EU MDR) dealer or importer are defined, which must be met with regard to the quality of the products and the certification requirements. In addition, QSVs regulate the obligation to examine and give notice of defects, which exist as part of the incoming goods inspection. Recently, the agreements have been increasingly checked by notified bodies and monitoring authorities and demanded by the manufacturers. The seminar explains what content the QAAs must have and how individual regulations can be designed in order to meet the regulatory requirements on the one hand and to avoid liability risks on the other.
topic overview
- Legal framework
- Minimum requirements for QAA
- Obligation to examine and complain during incoming goods inspection
- Audit Rights
- Delimitation of the responsibilities of the parties with regard to product liability
- "OEM" and "PLM" as a special supplier relationship - special features under the EU-MDR
- QSV on the sales side
- Relationship between QAA and framework supply contracts
target group
Managing directors and board members, executives and employees of manufacturers, dealers and importers of medical devices and medical technology retailers.
previous knowledge
Not mandatory.
KONTAKT:
Online
