content
DIN EN ISO 13485:2016 is the globally recognized standard for medical device quality management - and the basis of many regulatory certifications (EU-MDR, MDSAP, etc.) and approvals. It contains requirements for the operational organization of manufacturers, service providers and relevant suppliers to minimize clinical risks. The recommended process-oriented presentation in company-specific management, core and support processes will be presented in the seminar. It is also highlighted how suppliers and service providers who work for manufacturers of medical products 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, from suppliers and service providers for the medical technology industry, internal auditors.
previous knowledge
Not mandatory.
KONTAKT:
Online
