Content
DIN EN ISO 13485 is the globally recognized standard for medical device quality management - and the basis for many regulatory certifications (EU-MDR, MDSAP, etc.) and approvals. It includes requirements for the operational organization of manufacturers, service providers and relevant suppliers to minimize clinical risks. The recommended process-oriented presentation of company-specific leadership, core and support processes will be presented in the seminar. It also highlights how suppliers and service providers who work for manufacturers of medical devices can apply the standard as required and implement existing processes and procedures in their QM system in accordance with the standard.
Topic overview
- Presentation of the structure and content of DIN EN ISO 13485
- Relevant components for suppliers and service providers
- Practical tips for implementing and maintaining the QM system
- Interfaces of DIN EN ISO 13485 to Regulatory Affairs (EU-MDR/FDA, etc.)
target group
Employees from QM, suppliers and service providers for the medical technology industry, internal auditors.
Prior knowledge
Not required.
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:
TuttlingenTuttlingen & Online
